Minocycline Extended Release Tablets

•     45 mg extended release tablets: grey coloured capsule shaped film coated tablets, debossed with “45”on one side, plain on other side.

•     90 mg extended release tablets: yellow coloured capsule shaped film coated tablets, debossed with “90”on one side, plain on other side.

•     135 mg extended release tablets: pink (orange-brown) coloured capsule shaped film coated tablets, debossed with “135”on one side, plain on other side

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 Minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

Pharmacodynamics

The pharmacodynamics of Minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

Pharmacokinetics

Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, Minocycline hydrochloride extended-release tablets produce a delayed Tmax at 3.5 to 4.0 hours as compared to a non-modified release reference minocycline product (Tmax at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC(0-24) and Cmax were 33.32mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules,respectively. These parameters are based on dose adjusted to 135 mg per day for both product.
A single-dose, four-way crossover study demonstrated that Minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, Minocycline hydrochloride extended-release tablets 80 mg, and 105 mg were shown to be dose-proportional to Minocycline hydrochlorideextended-release tablets 90mg and 135 mg.
When Minocycline hydrochloride extended-release 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.

How Supplied

Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride equivalent to 45 mg, 90 mg or 135 mg minocycline, are supplied as follows. The 45 mg extended release tablets are gray coloured capsule shaped film coated tablets, debossed with “45” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows:

The 90 mg extended release tablets are yellow coloured capsule shaped film coated tablets, debossed with “90” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows:

The 135 mg extended release tablets are pink (orange brown) coloured capsule shaped film coated tablets, debossed with “135” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows:

Storage

Store at 20˚ to 25˚ (68˚ to 77˚ F) [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.

Use this medicine (minocycline extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Take this medicine at the same time of day.
• Take with or without food. Take with food if it causes an upset stomach.
• Do not take products that have iron in them or products like antacids that have aluminum, calcium, or magnesium in them at the same time as this medicine (minocycline extended-release tablets). Talk with your doctor or pharmacist.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Take with a full glass of water.
• Swallow whole. Do not chew or crush.
• Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).
• Dizziness.
• Feeling sleepy.
• Upset stomach or throwing up.
• Not hungry.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Get rid of this medicine (minocycline extended-release tablets) when you no longer need it.
• Do not take this medicine if it is outdated.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.