Solodyn

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

Mechanism of Action

The mechanism of action of SOLODYN for the treatment of acne is unknown.

Pharmacodynamics

The pharmacodynamics of SOLODYN for the treatment of acne are unknown.

Pharmacokinetics

SOLODYN Tablets are not bioequivalent to non-modified release 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 SOLODYN Tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, SOLODYN Tablets 55 mg, 80 mg, and 105 mg were shown to be dose-proportional to SOLODYN Tablets 90 mg and 135 mg.

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.

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

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, trials 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.

Table 3: Clinical Studies Dosing Table

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

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

You should not take this medicine if you are allergic to minocycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

To make sure you can safely take minocycline, tell your doctor if you have any of these other conditions:

• liver disease;
• kidney disease;
• asthma or sulfite allergy; or
• if you are also using a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen).

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. Do not use minocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Minocycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using minocycline.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking minocycline.

Children should not use minocycline. Minocycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Solodyn is a prescription antibiotic used to treat moderate to severe acne in patients 12 or older. Solodyn belongs to a group of drugs tetracycline antibiotics. It works by preventing the growth and spread of bacteria that cause acne.

This medication comes as an extended-release (long-acting) tablet. It is usually taken once a day, with or without food.

Do not chew, divide, or break extended-release tablets. Swallow tablets whole.

Common side effects include headache, tiredness, and itching.

Solodyn can also cause dizziness. Do not drive or operate heavy machinery until you know how Solodyn affects you.

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Minocycline may affect the way other medicines work, and other medicines may affect how minocycline works.

Especially tell your doctor if you take:

• birth control pills. Minocycline may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline.
• a blood thinner medicine.
• a penicillin antibiotic medicine. Minocycline and penicillins should not be used together.
• antacids that contain aluminum, calcium, or magnesium or iron-containing products.
• an acne medicine that contains isotretinoin (Amnesteem, Claravis, Sotret). Minocycline and isotretinoin should not be used together.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Call your doctor at once if you have:

• kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

• liver or pancreas problems--nausea, vomiting, upper stomach pain that may spread to your back, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, vision problems, pain behind your eyes;

• signs of inflammation in your body--swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, chest pain, new or worsening cough with fever, trouble breathing; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, diarrhea, loss of appetite;

• dizziness, spinning sensation;

• headache;

• swollen tongue, cough, trouble swallowing;

• muscle or joint pain;

• rash; or

• discoloration of you skin or nails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This section provides information on the proper use of a number of products that contain minocycline. It may not be specific to Solodyn. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. This medicine is not for long-term use.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule, extended-release capsule, or tablet whole with water. Do not, crush, break, or chew it.

You may take this medicine with or without food. Taking this medicine with food may lower your chances of irritation or ulcers in your esophagus (tube that connects mouth to the stomach).

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For infections:
    • Adults—At first, 200 milligrams (mg) followed by 100 mg every 12 hours. Some patients may start at 2 or 4 capsules of 50 mg followed by one 50 mg capsule 4 times a day.
    • Children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. The initial dose is usually 4 milligram (mg) per kilogram (kg) of body weight followed by 2 mg per kg of body weight every 12 hours. However, the dose should not be more than the usual adult dose.
    • Children younger than 8 years of age—Use is not recommended.
• For oral dosage forms (extended-release capsules or tablets):
  • For treatment of acne vulgaris:
    • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day for 12 weeks.
    • Children 8 to 12 years of age—Use and dose must be determined by your doctor.
    • Children younger than 8 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred or double vision
• bulging soft spot on the head of an infant
• chest pain, possibly moving to the left arm, neck, or shoulder
• confusion
• diarrhea
• dizziness or lightheadedness
• eye pain
• fast heartbeat
• general feeling of discomfort or illness
• general tiredness and weakness
• hives, itching, or skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea or vomiting
• red skin lesions, often with a purple center
• severe headache
• severe stomach pain
• sores, ulcers, or white spots on the lips or in the mouth
• troubled breathing
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Continuing ringing or buzzing or other unexplained noise in the ears
• difficulty with moving
• hearing loss
• hives or welts
• muscle stiffness
• redness of the skin
• sleepiness or unusual drowsiness

• Bloating
• discoloration of the tooth
• increased sensitivity of the skin to sunlight
• indigestion
• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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.

The two primary efficacy endpoints were:

Efficacy results are presented in Table 1.

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

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.

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.

NDC 99207-463-30
Rx Only

65 mg*

30 TABLETS

Solodyn®
(MINOCYCLINE HCl, USP)
EXTENDED RELEASE TABLETS

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.