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:

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, and 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.

Last updated on RxList: 8/10/2009

SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory lesions. Safety of SOLODYN has not been established beyond 12 weeks of use.

This formulation of minocycline has not been evaluated in the treatment of infections.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.

The recommended dosage of SOLODYN® is approximately 1 mg/kg 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 3: Dosing Table for SOLODYN®

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 Tablets may be taken with or without food (see CLINICAL PHARMACOLOGY). Ingestion of food along with

SOLODYN may help reduce the risk of esophageal irritation and ulceration.

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

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.

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
NDC 99207-463-10	Bottle of 100

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
NDC 99207-464-10	Bottle of 100

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

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

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 L6H 1M5.

Last updated on RxList: 8/10/2009

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. However, adverse reaction information from clinical trials provides a basis for identifying the adverse events that appear to be related to drug use.

Adverse events reported in clinical trials for SOLODYN® are described below in Table 2.

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

Adverse Event	SOLODYN® (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)

Adverse reactions not observed in the clinical trials, but 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 lupus-like 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 Carcinogenesis, Mutagenesis, Impairment of Fertility section).

1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
4. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.
5. In a multi-center study to evaluate the effect of SOLODYN® on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN® 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.

Last updated on RxList: 8/10/2009

Teratogenic effects

1) 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 should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child (see PRECAUTIONS: Impairment of Fertility & Pregnancy).

2) 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.

3) 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 PRECAUTIONS: Pregnancy section).

Gastro-intestinal effects

1. 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.

2. 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

1. 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.
2. 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.

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.

General

Safety of SOLODYN beyond 12 weeks of use has not been established.

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

Bacterial resistance to the tetracyclines may develop in patients using SOLODYN , 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 , it should be used only as indicated.

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.

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.

Information for Patients

(See Patient Package Insert that accompanies this Package Insert for additional information to give patients)

1. 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.
2. Patients who experience central nervous system symptoms (see WARNINGS) should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should also be cautioned about seeking medical help for headaches or blurred vision.
3. Concurrent use of tetracycline may render oral contraceptives less effective (See DRUG INTERACTIONS).
4. Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class antibiotics, 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.
5. Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy.
6. Take SOLODYN 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.
7. SOLODYN should not be used by pregnant women or women attempting to conceive a child (See Pregnancy, Carcinogenesis and Mutagenesis sections).
8. It is recommended that SOLODYN not be used by men who are attempting to father a child (See Impairment of Fertility section).

Laboratory Tests

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

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

Pregnancy

Teratogenic Effects

Pregnancy category D
(See WARNINGS)

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, 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®). 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®).

SOLODYN® 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.

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).

Pediatric Use

SOLODYN® 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).

Geriatric Use

Clinical studies of SOLODYN® 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.

Last updated on RxList: 8/10/2009

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

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

Last updated on RxList: 8/10/2009

Pharmacokinetics

SOLODYN Tablets are not bioequivalent to minocycline products. Based on pharmacokinetic studies in healthy adults, SOLODYN 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 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 Tablets (45 mg, 90 mg, and 135 mg) exhibited dose-proportional pharmacokinetics.

When SOLODYN 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.

Microbiology

Minocycline is bacteriostatic exerting its antimicrobial effect by the inhibition of bacterial protein synthesis. Minocycline is lipid soluble and distributes in to the skin and sebum. Minocycline has been shown to have in vitro activity against Propionibacterium acnes, an organism associated with acne vulgaris, however, the clinical significance of this activity against P. acnes in patients with acne vulgaris is not known.

Clinical Studies

The safety and efficacy of SOLODYN 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 or placebo for a total of 12 weeks, according to the following dose assignments.

Subject's Weight (lbs)	Subject's Weight (kg)	Available Caplet Strength (mg)	Actual mg/kg Dose
99 – 131	45.00 – 59.54	45	1.00 – 0.76
132 – 199	60.00 – 90.45	90	1.50 – 1.0
200 – 300	90.91 – 136.36	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 1.

Table 1 - Efficacy Results at Week 12

	Study 1		Study 2
	SOLODYN® (1 mg/kg) N = 300	Placebo N = 151	SOLODYN® (1 mg/kg) N = 315	Placebo N = 158
Mean Percent Improvement in Inflammatory Lesions	43.1%	31.7%	45.8%	30.8%
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 did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

Last updated on RxList: 8/10/2009

SOLODYN® (SO-lo-d#n) Extended Release Tablets
(minocycline HCl, USP) Rx only

Read all patient information that comes with SOLODYN® 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®?

SOLODYN® is a tetracycline-class antibiotic medicine that contains minocycline. SOLODYN® 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® has not been studied for use longer than 12 weeks.

SOLODYN® has not been studied or the treatment of infections.

Who should not take SOLODYN®?

Do not take SOLODYN® 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®.

SOLODYN® should not be used by pregnant women, women attempting to conceive a child, or children up to 8 years old because:

1. SOLODYN® may harm an unborn baby
2. SOLODYN® may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. SOLODYN® 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® not be used by men who are attempting to father a child.

What should I tell my doctor before taking SOLODYN®?

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® may harm your unborn baby. Stop taking SOLODYN® and call your doctor if you become pregnant while taking it.
• are breastfeeding. SOLODYN® passes into your milk and may harm your baby. You should decide whether to use SOLODYN® 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® and other medicines may interact. Especially tell your doctor if you take:

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

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

How should I take SOLODYN®?

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

What are possible side effects of SOLODYN®?

SOLODYN® may cause serious side effects.

Stop SOLODYN® 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® may also cause:

• central nervous system effects. Symptoms include light-headedness, 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®. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in sunlight. Stop SOLODYN® 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® include:

• headache
• nausea
• tiredness
• dizziness or spinning feeling
• diarrhea
• stomach area pain
• 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®. Ask your doctor or pharmacist for more information.

How should I store SOLODYN®?

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

General Information about SOLODYN®

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use SOLODYN® for a condition for which it was not prescribed. Do not give SOLODYN® 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®. If you would like more information, talk to your doctor.

You can ask your doctor or pharmacist for information about SOLODYN® that is written for health professionals.

What are the Ingredients in SOLODYN®?

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

Last updated on RxList: 8/10/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

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. Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can destroy the long action of the drug and may increase side effects. 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 30 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.

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 (pseudomembranous colitis) 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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call 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.

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. Use caution while driving, using machinery, or doing any activity that requires alertness. 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.

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, 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, ergot alkaloids and derivatives (e.g., ergotamine), live bacterial vaccines, penicillins, warfarin.

This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

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.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.