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Solodyn

Solodyn


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Solodyn Drug Description


SOLODYN®
(minocycline HCl) Extended Release Tablets for Oral Use

DRUG DESCRIPTION

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide

mono hydrochloride. The structural formula is represented below:

 

SOLODYN®   (minocycline HCl) Structural Formula Illustration

C23H27N3O7•HCl.........................M. W. 493.95

SOLODYN® Tablets for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg of minocycline. In addition, 45 mg, 65 mg, 90 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain Opadry II Gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain Opadry II Yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2. The 135 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.

 

What are the possible side effects of minocycline (Dynacin, Minocin, Minocin PAC, Myrac, Solodyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using minocycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or...

Read All Potential Side Effects and See Pictures of Solodyn »

 

What are the precautions when taking minocycline hydrochloride (Solodyn)?

Before taking minocycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., doxycycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), lupus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and...

 

Solodyn


Solodyn Indications & Dosage


INDICATIONS

Indication

SOLODYN® (minocycline hydrochloride) is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Limitations of Use

SOLODYN® (minocycline hydrochloride) did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN® (minocycline hydrochloride) has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies].

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN® (minocycline hydrochloride) should be used only as indicated [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

The recommended dosage of SOLODYN® (minocycline hydrochloride) is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.

The following table shows tablet strength and body weight to achieve approximately 1 mg/kg.

Table 1: Dosing Table for SOLODYN® (minocycline hydrochloride)

Patient's Weight (lbs.) Patient's Weight (kg) Tablet Strength (mg) Actual mg/kg Dose
99 – 120 45 – 54 45 1– 0.83
121 – 170 55 – 77 65 1.18 – 0.84
171 – 225 78 – 102 90 1.15 – 0.88
226 – 276 103 – 125 115 1.12 – 0.92
277 – 300 126 – 136 135 1.07 – 0.99

SOLODYN (minocycline hydrochloride) ® Tablets may be taken with or without food [see CLINICAL PHARMACOLOGY]. Ingestion of food along with SOLODYN® (minocycline hydrochloride) may help reduce the risk of esophageal irritation and ulceration.

In patients with renal impairment [see WARNINGS AND PRECAUTIONS], the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses.

HOW SUPPLIED

Dosage Forms And Strengths

  • 45 mg extended release tablets: gray, unscored, coated, and debossed with “DYN-045" on one side.
  • 65 mg extended release tablets: blue, unscored, coated, and debossed with “DYN-065" on one side.
  • 90 mg extended release tablets: yellow, unscored, coated, and debossed with “DYN-090" on one side.
  • 115 mg extended release tablets: green, unscored, coated, and debossed with “DYN-115" on one side.
  • 135 mg extended release tablets: pink (orange-brown), unscored, coated, and debossed with “DYN-135" on one side.

SOLODYN® (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg minocycline, are supplied as follows.

The 45 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-045” on one side. Each tablet contains minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows:

NDC 99207-460-30 Bottle of 30
NDC 99207-460-10 Bottle of 100

The 65 mg extended release tablets are blue, unscored, coated, and debossed with “DYN-065” on one side. Each tablet contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:

NDC 99207-463-30 Bottle of 30

The 90 mg extended release tablets are yellow, unscored, coated, and debossed with “DYN-090” on one side. Each tablet contains minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows:

NDC 99207-461-30 Bottle of 30
NDC 99207-461-10 Bottle of 100

The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows:

NDC 99207-464-30 Bottle of 30

The 135 mg extended release tablets are pink (orange-brown), unscored, coated, and debossed with “DYN-135” on one side. Each tablet contains minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows:

NDC 99207-462-30 Bottle of 30
NDC 99207-462-10 Bottle of 100

Storage

Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].

Handling

Keep out of reach of children.

Protect from light, moisture, and excessive heat.

Dispense in tight, light-resistant container with child-resistant closure.

Manufactured for: Medicis, The Dermatology Company, Scottsdale, AZ 85256. Manufactured by: WellSpring Pharmaceutical Canada Corp. Oakville, Ontario, CANADA L6H 1M5

Solodyn


Solodyn Side Effects & Drug Interactions


SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice.

The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥ 1% for SOLODYN® (minocycline hydrochloride) .

Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects

Adverse Reactions SOLODYN® (minocycline hydrochloride)
(1 mg/kg)
N = 674 (%)
PLACEBO
N = 364 (%)
At least one treatment-emergent event 379 (56) 197 (54)
Headache 152 (23) 83 (23)
Fatigue 62 (9) 24 (7)
Dizziness 59 (9) 17 (5)
Pruritus 31 (5) 16 (4)
Malaise 26 (4) 9 (3)
Mood alteration 17 (3) 9 (3)
Somnolence 13 (2) 3 (1)
Urticaria 10 (2) 1 (0)
Tinnitus 10 (2) 5 (1)
Arthralgia 9 (1) 2 (0)
Vertigo 8 (1) 3 (1)
Dry mouth 7 (1) 5 (1)
Myalgia 7 (1) 4 (1)

Postmarketing Experience

Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include:

Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupuslike syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: thyroid discoloration, abnormal thyroid function.

Oncology: papillary thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see Nonclinical Toxicology].

DRUG INTERACTIONS

Anticoagulants

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Penicillin

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Methoxyflurane

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Antacids and Iron Preparations

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

Low Dose Oral Contraceptives

In a multi-center study to evaluate the effect of SOLODYN® (minocycline hydrochloride) on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN® (minocycline hydrochloride) 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

 

Solodyn


Solodyn Side Effects & Drug Interactions


SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice.

The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥ 1% for SOLODYN® (minocycline hydrochloride) .

Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects

Adverse Reactions SOLODYN® (minocycline hydrochloride)
(1 mg/kg)
N = 674 (%)
PLACEBO
N = 364 (%)
At least one treatment-emergent event 379 (56) 197 (54)
Headache 152 (23) 83 (23)
Fatigue 62 (9) 24 (7)
Dizziness 59 (9) 17 (5)
Pruritus 31 (5) 16 (4)
Malaise 26 (4) 9 (3)
Mood alteration 17 (3) 9 (3)
Somnolence 13 (2) 3 (1)
Urticaria 10 (2) 1 (0)
Tinnitus 10 (2) 5 (1)
Arthralgia 9 (1) 2 (0)
Vertigo 8 (1) 3 (1)
Dry mouth 7 (1) 5 (1)
Myalgia 7 (1) 4 (1)

Postmarketing Experience

Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include:

Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupuslike syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: thyroid discoloration, abnormal thyroid function.

Oncology: papillary thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see Nonclinical Toxicology].

DRUG INTERACTIONS

Anticoagulants

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Penicillin

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Methoxyflurane

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Antacids and Iron Preparations

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

Low Dose Oral Contraceptives

In a multi-center study to evaluate the effect of SOLODYN® (minocycline hydrochloride) on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN® (minocycline hydrochloride) 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

 

Solodyn


Solodyn Warnings & Precautions


WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Teratogenic Effects

A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

SOLODYN® (minocycline hydrochloride) should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child [see Nonclinical Toxicology & Use in Specific Populations].

B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT.

C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Use in Specific Populations].

Pseudomembranous Colitis

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Hepatotoxicity

Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne.

Metabolic Effects

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Central Nervous System Effects

Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.

Benign Intracranial Hypertension

Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines and should be routinely checked for papilledema while on treatment. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

Autoimmune Syndromes

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

Photosensitivity

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

Serious Skin/Hypersensitivity Reaction

Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with minocycline use in treatment of acne.

Tissue Hyperpigmentation

Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Development of Drug Resistant Bacteria

Bacterial resistance to the tetracyclines may develop in patients using SOLODYN® (minocycline hydrochloride) , therefore, the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for drug-resistant bacteria to develop during the use of SOLODYN® (minocycline hydrochloride) , it should be used only as indicated.

Superinfection

As with other antibiotic preparations, use of SOLODYN® (minocycline hydrochloride) may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Laboratory Monitoring

Periodic laboratory evaluations of organ systems, including hematopoetic renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

Information for Patients

Patients taking SOLODYN® (minocycline HCl, USP) Extended Release Tablets should receive the following information and instructions:

  • SOLODYN® (minocycline hydrochloride) should not be used by pregnant women or women attempting to conceive a child [see Use in Specific Populations, Nonclinical Toxicology).
  • It is recommended that SOLODYN® (minocycline hydrochloride) not be used by men who are attempting to father a child [see Nonclinical Toxicology].
  • Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention
  • Patients should be counseled about the possibility of hepatotoxicity. Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness.
  • Patients who experience central nervous system symptoms [see WARNINGS AND PRECAUTIONS] should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should seek medical help for persistent headaches or blurred vision.
  • Concurrent use of tetracycline may render oral contraceptives less effective [see DRUG INTERACTIONS].
  • Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
  • Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy.
  • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema.
  • SOLODYN® (minocycline hydrochloride) should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.
  • Patients should be advised to swallow SOLODYN® (minocycline hydrochloride) tablets whole and not to chew, crush, or split the tablets.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis - Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.

Mutagenesis - Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Impairment of Fertility - Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN® (minocycline hydrochloride) ). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN® (minocycline hydrochloride) ) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

SOLODYN® (minocycline hydrochloride) should not be used by individuals of either gender who are attempting to conceive a child.

Use In Specific Populations

Pregnancy

Teratogenic Effects: Pregnancy category D

[see WARNINGS AND PRECAUTIONS]

SOLODYN® (minocycline hydrochloride) should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately.

There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman.

Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of SOLODYN® (minocycline hydrochloride) ). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN® (minocycline hydrochloride) ).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of SOLODYN® (minocycline hydrochloride) ). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

Nursing Mothers

Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see WARNINGS AND PRECAUTIONS].

Pediatric Use

SOLODYN® (minocycline hydrochloride) is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established.

Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see WARNINGS AND PRECAUTIONS].

Geriatric Use

Clinical studies of SOLODYN® (minocycline hydrochloride) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

 

 

Solodyn


Solodyn Overdosage & Contraindications


OVERDOSE

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

CONTRAINDICATIONS

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

 

Solodyn

 

Solodyn Clinical Pharmacology


CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of SOLODYN® (minocycline hydrochloride) for the treatment of acne is unknown.

Pharmacodynamics

The pharmacodynamics of SOLODYN® (minocycline hydrochloride) for the treatment of acne are unknown.

Pharmacokinetics

SOLODYN® (minocycline hydrochloride) Tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, SOLODYN® (minocycline hydrochloride) Tablets produce a delayed Tmax at 3.5–4.0 hours as compared to a non-modified release reference minocycline product (Tmax at 2.25–3 hours). At steady-state (Day 6), the mean AUC(0–24) and Cmax were 33.32 µg×hr/mL and 2.63 µg/mL for SOLODYN® (minocycline hydrochloride) Tablets and 46.35 µg×hr/mL and 2.92 µg/mL for Minocin® capsules, respectively. These parameters are based on dose adjusted to 135 mg per day for both products.

A single-dose, four-way crossover study demonstrated that all strengths of SOLODYN® (minocycline hydrochloride) Tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics.

When SOLODYN® (minocycline hydrochloride) Tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions.

Minocycline is lipid soluble and distributes into the skin and sebum.

Clinical Studies

The safety and efficacy of SOLODYN® (minocycline hydrochloride) in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled, studies in subjects ≥ 12 years. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%).

In two efficacy and safety trials, a total of 924 subjects with non-nodular moderate to severe acne vulgaris received SOLODYN® (minocycline hydrochloride) or placebo for a total of 12 weeks, according to the following dose assignments.

Table 3: Clinical Studies Dosing Table

Subject's Weight (lbs) Subject's Weight (kg) Available Caplet Strength (mg) Actual mg/kg Dose
99 – 131 45 – 59 45 1 – 0.76
132 – 199 60 – 90 90 1.5 – 1
200 – 300 91 – 136 135 1.48 – 0.99

The two primary efficacy endpoints were:

  1. Mean percent change in inflammatory lesion counts from Baseline to 12 weeks.
  2. Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks.

Efficacy results are presented in Table 4.

Table 4: Efficacy Results at Week 12

Study 1 Study 2
SOLODYN® (minocycline hydrochloride)
(1 mg/kg)
N = 300
Placebo
N = 151
SOLODYN® (minocycline hydrochloride)
(1 mg/kg)
N = 315
Placebo
N = 158
Mean Percent Improvement in 43.1% 31.7% 45.8% 30.8%
Inflammatory Lesions No. (%) of Subjects Clear or Almost Clear on the EGSA* 52 (17.3%) 12 (7.9%) 50 (15.9%) 15 (9.5%)
*Evaluator's Global Severity Assessment

SOLODYN® (minocycline hydrochloride) did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

 

Solodyn


Solodyn Medication Guide


PATIENT INFORMATION

SOLODYN®
(SO-lo-dIn)
(minocycline HCl, USP) Extended Release Tablets

Read all patient information that comes with SOLODYN® (minocycline hydrochloride) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of speaking with your doctor about your condition or treatment.

What is SOLODYN® (minocycline hydrochloride) ?

SOLODYN® (minocycline hydrochloride) is a tetracycline-class drug that contains minocycline. SOLODYN® (minocycline hydrochloride) is only for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 12 years and older. SOLODYN® (minocycline hydrochloride) did not show any effect on acne spots that were not red-looking.

SOLODYN® (minocycline hydrochloride) has not been studied for use longer than 12 weeks.

SOLODYN® (minocycline hydrochloride) has not been studied for the treatment of infections.

Who should not take SOLODYN® (minocycline hydrochloride) ?

Do not take SOLODYN® (minocycline hydrochloride) if you are allergic to minocycline or any other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this leaflet for a complete list of ingredients in SOLODYN® (minocycline hydrochloride) .

SOLODYN® (minocycline hydrochloride) should not be used by pregnant women, women attempting to have a child, or children up to 8 years old because:

  1. SOLODYN® (minocycline hydrochloride) may harm an unborn baby
  2. SOLODYN® (minocycline hydrochloride) may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. SOLODYN® (minocycline hydrochloride) should not be used during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years.

It is recommended that SOLODYN® (minocycline hydrochloride) not be used by men who are attempting to father a child.

What should I tell my doctor before taking SOLODYN® (minocycline hydrochloride) ?

Tell your doctor about all of your medical conditions including if you:

  • have kidney problems. Your doctor may prescribe a lower dose of medicine for you.
  • have any vision problems such as blurred vision.
  • are pregnant or attempting to conceive a child. SOLODYN® (minocycline hydrochloride) may harm your unborn baby. Stop taking SOLODYN® (minocycline hydrochloride) and call your doctor if you become pregnant while taking it.
  • are breastfeeding. SOLODYN® (minocycline hydrochloride) passes into your milk and may harm your baby. You should decide whether to use SOLODYN® (minocycline hydrochloride) or breastfeed, but not both.

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. SOLODYN® (minocycline hydrochloride) and other medicines may interact. Especially tell your doctor if you take:

  • birth control pills. SOLODYN® (minocycline hydrochloride) may make your birth control pills less effective. You should use a second form of birth control while taking SOLODYN® (minocycline hydrochloride)
  • a blood thinner medicine. The dose of your blood thinner may be lowered.
  • a penicillin antibiotic medicine. SOLODYN® (minocycline hydrochloride) and penicillins should not be used together.
  • antacids that contain aluminum, calcium, or magnesium or iron-containing products. These can affect how much SOLODYN® (minocycline hydrochloride) passes into your body.
  • An acne medication that contains isotretinoin. SOLODYN® (minocycline hydrochloride) and isotretinoin should not be used together.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I take SOLODYN® (minocycline hydrochloride) ?

  • SOLODYN® (minocycline hydrochloride) comes in 5 strengths. Your doctor will prescribe the strength that is best for your body weight. The usual dose of SOLODYN® (minocycline hydrochloride) is 1 tablet each day for 12 weeks.
  • Take SOLODYN® (minocycline hydrochloride) at the same time each day, with or without food. Taking SOLODYN® (minocycline hydrochloride) with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
  • Swallow SOLODYN® (minocycline hydrochloride) Tablets whole. Do not chew, crush, or split the tablets.
  • If you forget to take SOLODYN® (minocycline hydrochloride) , take it as soon as you remember. Do not take more than one tablet of SOLODYN® (minocycline hydrochloride) in one day.
  • If you take too much SOLODYN® (minocycline hydrochloride) at a time, call your doctor.
  • If you do not notice an improvement in your acne after 12 weeks of treatment with SOLODYN® (minocycline hydrochloride) , call your doctor.

What are possible side effects of SOLODYN® (minocycline hydrochloride) ?

SOLODYN® (minocycline hydrochloride) may cause serious side effects. Stop SOLODYN® (minocycline hydrochloride) and call your doctor if you have:

  • watery diarrhea
  • bloody stools
  • stomach cramps
  • unusual headaches
  • blurred vision
  • fever
  • rash
  • joint pain
  • feeling very tired

SOLODYN® (minocycline hydrochloride) may also cause:

  • serious effects on the liver. Symptoms can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness. If you have these symptoms, stop SOLODYN® (minocycline hydrochloride) and call your doctor.
  • central nervous system effects. Symptoms include lightheadedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate dangerous machines if you have these symptoms.
  • sun sensitivity (photosensitivity). You may get a worse sunburn with SOLODYN® (minocycline hydrochloride) Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in sunlight. Stop SOLODYN® (minocycline hydrochloride) and call your doctor at the first sign of redness or sunburn.
  • darkening of skin, scars, teeth, and gums.

The most common side effects with SOLODYN® (minocycline hydrochloride) include:

  • headache
  • tiredness
  • dizziness or spinning feeling
  • itching

Call your doctor if you have a side effect that bothers you or that does not go away.

These are not all the side effects with SOLODYN® (minocycline hydrochloride) Ask your doctor or pharmacist for more information.

You may report side effects to FDA at 1-800-FDA-1088 or to Medicis at 1-800-900-6389.

How should I store SOLODYN® (minocycline hydrochloride) ?

  • Store SOLODYN® (minocycline hydrochloride) at room temperature. Keep SOLODYN® (minocycline hydrochloride) Tablets in the bottle you received from the pharmacy and store away from moisture and light.
  • Keep SOLODYN® (minocycline hydrochloride) and all medicines out of the reach of children.

General Information about SOLODYN® (minocycline hydrochloride)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use SOLODYN® (minocycline hydrochloride) for a condition for which it was not prescribed. Do not give SOLODYN® (minocycline hydrochloride) to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about SOLODYN® (minocycline hydrochloride) . If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SOLODYN® (minocycline hydrochloride) that is written for health professionals.

What are the Ingredients in SOLODYN®?

Active Ingredient: minocycline HCl USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg of minocycline.

Inactive Ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain Opadry II Gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain Opadry II Yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, FD&C Blue #2. The 135 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.

 

Solodyn


Solodyn Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MINOCYCLINE EXTENDED-RELEASE TABLET - ORAL

 

(min-oh-SYE-kleen)

 

COMMON BRAND NAME(S): Solodyn

 

USES: This medication is used to treat moderate to severe acne in patients 12 years of age and older. It helps to reduce the number of pimples. Minocycline belongs to the class of antibiotics known as tetracyclines. It works by stopping the growth of bacteria that may worsen acne.

This antibiotic is approved to treat acne that is thought to be caused by a bacterial infection. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Take each dose with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication. For this reason, do not take it right before bedtime. You may take this medication with food or milk to lower the chance of irritating the esophagus and stomach unless your doctor directs you otherwise.

Take this medication 2-3 hours before or after taking any medications containing magnesium, aluminum, or calcium. Some examples include antacids, quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and sucralfate. Follow the same instructions if you also take bismuth subsalicylate, iron, and zinc. They bind with minocycline preventing its full absorption.

Dosage is based on your medical condition, weight, and response to therapy.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication for the prescribed length of time. Do not skip doses. Stopping the medication too early or skipping doses may allow bacteria to continue to grow and increase the risk of developing resistant bacteria that are more difficult to treat.

Inform your doctor if your condition does not improve after 3 months of treatment or if it worsens.

 

Solodyn


Solodyn Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, lightheadedness, dizziness, unsteadiness, drowsiness, mild headache, mouth sores, or cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), muscle pain, difficult/painful swallowing, change in the amount of urine, pink urine, brown/gray tooth discoloration, blue/gray/brown discoloration of the skin/lips/tongue/gums, numbness/tingling of the hands/feet, unusual tiredness, new signs of infection (e.g., fever, chills, persistent sore throat).

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, unusual/severe headache, vision changes (e.g., blurred vision).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (fungal infections). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, swollen glands, chest pain, fast/irregular heartbeat, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before taking minocycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., doxycycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), lupus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using minocycline.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. It should not be used in women or men trying to have a child. Women of child-bearing age and men should use effective birth control while taking this medication. Consult your doctor for more details. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

 

Solodyn


Solodyn Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, lightheadedness, dizziness, unsteadiness, drowsiness, mild headache, mouth sores, or cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), muscle pain, difficult/painful swallowing, change in the amount of urine, pink urine, brown/gray tooth discoloration, blue/gray/brown discoloration of the skin/lips/tongue/gums, numbness/tingling of the hands/feet, unusual tiredness, new signs of infection (e.g., fever, chills, persistent sore throat).

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, unusual/severe headache, vision changes (e.g., blurred vision).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (fungal infections). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, swollen glands, chest pain, fast/irregular heartbeat, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before taking minocycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., doxycycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), lupus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using minocycline.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. It should not be used in women or men trying to have a child. Women of child-bearing age and men should use effective birth control while taking this medication. Consult your doctor for more details. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

 

Solodyn

Solodyn Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: acitretin, alitretinoin, isotretinoin, tretinoin taken by mouth.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting minocycline.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, live bacterial vaccines, penicillins, warfarin.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This product can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Do not take more than one dose per day.

 

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light, moisture, and extreme heat. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Taking outdated tetracycline-related drugs can result in serious illness. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Solodyn


Solodyn Patient Information Including Side Effects

Brand Names: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Generic Name: minocycline (Pronunciation: mye no SYE kleen)

 

  • What is minocycline (Solodyn)?
  • What are the possible side effects of minocycline (Solodyn)?
  • What is the most important information I should know about minocycline (Solodyn)?
  • What should I discuss with my healthcare provider before taking minocycline (Solodyn)?
  • How should I take minocycline (Solodyn)?
  • What happens if I miss a dose (Solodyn)?
  • What happens if I overdose (Solodyn)?
  • What should I avoid while taking minocycline (Solodyn)?
  • What other drugs will affect minocycline (Solodyn)?
  • Where can I get more information?

 

What is minocycline (Solodyn)?

Minocycline is a tetracycline antibiotic. It fights bacteria in the body.

Minocycline is used to treat many different bacterial infections, such as urinary tract infections, severe acne, gonorrhea, tick fever, chlamydia, and others.

Minocycline may also be used for other purposes not listed in this medication guide.

Dynacin 100 mg

gray/white, imprinted with 0498, DYNACIN 100 mg

What are the possible side effects of minocycline (Solodyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using minocycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, jaundice (yellowing of the skin or eyes); or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • sores or swelling in your rectal or genital area;
  • mild nausea, vomiting, diarrhea, or stomach upset;
  • white patches or sores inside your mouth or on your lips;
  • swollen tongue, trouble swallowing; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about minocycline (Solodyn)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby, including permanent discoloration of the teeth later in life. Minocycline can make birth control pills less effective. Use a second method of birth control while you are taking minoocycline to keep from getting pregnant.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give minocycline to a child younger than 8 years old. Minocycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Minocycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking minocycline. These products can make minocycline less effective.

Throw away any unused minocycline when it expires or when it is no longer needed. Do not take any minocycline after the expiration date printed on the label. Using expired minocycline can cause damage to your kidneys.

Related Drug Centers
  • Minocin Capsules
  • Solodyn
  • Minocin

 

Solodyn


Solodyn Patient Information including How Should I Take

In this Article

  • What is minocycline (Solodyn)?
  • What are the possible side effects of minocycline (Solodyn)?
  • What is the most important information I should know about minocycline (Solodyn)?
  • What should I discuss with my healthcare provider before taking minocycline (Solodyn)?
  • How should I take minocycline (Solodyn)?
  • What happens if I miss a dose (Solodyn)?
  • What happens if I overdose (Solodyn)?
  • What should I avoid while taking minocycline (Solodyn)?
  • What other drugs will affect minocycline (Solodyn)?
  • Where can I get more information?

What should I discuss with my healthcare provider before taking minocycline (Solodyn)?

Do not use this medication if you are allergic to minocycline, or to similar medicines such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking minocycline, tell your doctor if you have liver or kidney disease. You may not be able to take minocycline, or you may require a dosage adjustment or special monitoring during therapy.

If you are using minocycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. This medication can cause harm to an unborn baby, including permanent discoloration of the teeth later in life. Do not use minocycline without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Minocycline can make birth control pills less effective. Use a non-hormonal method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while you are taking minocycline.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give minocycline to a child younger than 8 years old. Minocycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

How should I take minocycline (Solodyn)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take each dose with a full glass (8 ounces) of water.

You may take this medication with or without food. Do not take the medication with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medicine. Certain brands of minocycline may not have restrictions about taking them with dairy products. If your doctor has instructed you to take minocycline with milk, tell your pharmacist that you need a brand of minocycline that can be taken with milk.

Do not crush, chew, or break an extended-release tablet (Solodyn). Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Minocycline will not treat a viral infection such as the common cold or flu. Do not give this medicine to another person, even if they have the same condition you have.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking demeclocycline. You may need to stop using the medicine for a short time.

Throw away any unused minocycline when it expires or when it is no longer needed. Do not take any minocycline after the expiration date printed on the label. Using expired minocycline can cause damage to your kidneys.

Store this medication at room temperature away from moisture and heat.

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Solodyn


Solodyn Patient Information including If I Miss a Dose

In this Article

  • What is minocycline (Solodyn)?
  • What are the possible side effects of minocycline (Solodyn)?
  • What is the most important information I should know about minocycline (Solodyn)?
  • What should I discuss with my healthcare provider before taking minocycline (Solodyn)?
  • How should I take minocycline (Solodyn)?
  • What happens if I miss a dose (Solodyn)?
  • What happens if I overdose (Solodyn)?
  • What should I avoid while taking minocycline (Solodyn)?
  • What other drugs will affect minocycline (Solodyn)?
  • Where can I get more information?

What happens if I miss a dose (Solodyn)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose (Solodyn)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, and diarrhea.

What should I avoid while taking minocycline (Solodyn)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Minocycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking minocycline. These products can make minocycline less effective.

What other drugs will affect minocycline (Solodyn)?

Before taking minocycline, tell your doctor if you are taking any of the following drugs:

  • cholesterol-lowering medications such as cholestyramine (Prevalite, Questran) or colestipol (Colestid);
  • isotretinoin (Accutane);
  • tretinoin (Renova, Retin-A, Vesanoid);
  • an antacid such as Tums, Rolaids, Milk of Magnesia, Maalox, and others;
  • a product that contains bismuth subsalicylate such as Pepto-Bismol;
  • minerals such as iron, zinc, calcium, magnesium, and over-the-counter vitamin and mineral supplements;
  • a blood thinner such as warfarin (Coumadin); or
  • a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, others), penicillin (BeePen-VK, Pen-Vee K, Veetids, others), dicloxacillin (Dynapen), carbenicillin (Geocillin), oxacillin (Bactocill), and others.

This list is not complete and there may be other drugs that can interact with minocycline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about minocycline.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


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  • Solodyn
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