Minocycline Hydrochloride (Page 4 of 5)

OVERDOSAGE

The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting.

No specific antidote for minocycline is known.

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

DOSAGE AND ADMINISTRATION

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Minocycline hydrochloride capsules may be taken with or without food (See CLINICAL PHARMACOLOGY).

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole.

For Pediatric Patients Above 8 Years Of Age
Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.

Adults
The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily.

Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days.

In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended.

For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.

In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.

Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least 7 days.

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.

The pharmacokinetics of minocycline in patients with renal impairment (CL CR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (See WARNINGS).

HOW SUPPLIED

Minocycline HCl Capsules, USP equivalent to 100 mg* minocycline with a gray opaque cap and white opaque body imprinted ” RX696 ” on cap and body in black ink and supplied as follows:
Unit dose packages of 50 (5 x 10) NDC 60687-336-65

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Protect from light, moisture and excessive heat.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

*The appearance of the product may vary depending on the source of the ingredients filled in the capsule.

ANIMAL PHARMACOLOGY AND TOXICOLOGY

Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard- Tenth Edition; CLSI Document M07- A10, Vol. 32, No. 2, January, 2015. Clinical and Laboratory Standards, 940 West Valley Rd., Suite 2500, Wayne, PA 19087-1898.
  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard- Twelfth Edition; CLSI Document M02- A12, Vol. 32, No. 1, January, 2015. Clinical and Laboratory Standards, 940 West Valley Rd., Suite 2500, Wayne, PA 19087-1898,
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-sixth Informational Supplement. Document M100-S26, Vol. 32, No. 3, January, 2016. Clinical and Laboratory Standards, 940 West Valley Rd., Suite 2500, Wayne, PA 19087-1898,

For further product information, call Torrent Pharmaceuticals Inc. at 1-800-912-9561.
For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from TORRENT PHARMA INC. as follows:
(100 mg / 50 UD) NDC 60687-336-65 packaged from NDC 13668-484

Distributed by:
American Health Packaging
Columbus, OH 43217

8433665/0722

PATIENT INFORMATION

8433665/0722

MINOCYCLINE HYDROCHLORIDE (Mi-no-syk-lin hi-droh-clor-ride) CAPSULES, USP
50 mg, 75 mg and 100 mg
Rx only

Read the Patient Information that comes with minocycline hydrochloride capsules, USP before you or a family member starts taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What are minocycline hydrochloride capsules, USP?
Minocycline hydrochloride capsules, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride capsules, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride capsules, USP may be used along with other treatments for severe acne.

Sometimes, other germs, called viruses cause infections. The common cold is a virus. Minocycline hydrochloride capsules, USP, like other antibiotics, do not treat viruses.

Who should not use minocycline hydrochloride capsules, USP?
Do not take minocycline hydrochloride capsules, USP if you are allergic to minocycline or other tetracycline antibiotics.
Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in minocycline hydrochloride capsules, USP.

Minocycline hydrochloride capsules, USP are not recommended for pregnant women or children up to 8 years old because:

  1. Minocycline hydrochloride capsules, USP may harm an unborn baby
  2. Minocycline hydrochloride capsules, USP may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years.

What should I tell my doctor before starting minocycline hydrochloride capsules, USP?
Tell your doctor about all of your medical conditions, including if you:

  • have liver or kidney problems
  • are pregnant or planning to become pregnant. Minocycline hydrochloride capsules, USP may harm your unborn baby. Stop taking minocycline hydrochloride capsules, USP and call your doctor if you become pregnant while taking them.
  • are breast feeding. Minocycline passes into your milk and may harm your baby. You should decide whether to use minocycline hydrochloride capsules, USP or breastfeed, but not both.

Tell your doctor about all the medicines you are taking including prescription and non-prescription medications, vitamins, and herbal supplements. Minocycline hydrochloride capsules, USP and other medicines may interact. Especially tell your doctor if you take:

  • birth control pills. Minocycline hydrochloride capsules, USP may make your birth control pills less effective.
  • a blood thinner medicine. The dose of your blood thinner may have to be lowered.
  • a penicillin antibiotic medicine. Minocycline hydrochloride capsules, USP and penicillins should not be used together.
  • Migraine medicines called ergot alkaloids.
  • An acne medicine called isotretinoin (Accutane, Amnesteem, Claravis, Sotret).
  • Antacids that contain aluminum, calcium, or magnesium, or iron-containing products.

Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.

How should I take minocycline hydrochloride capsules, USP?

  • Take minocycline hydrochloride capsules, USP exactly as your doctor tells you to take them. Skipping doses or not taking all your minocycline hydrochloride capsules, USP may:
  • Decrease the effectiveness of the treatment
  • Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules, USP
  • Take minocycline hydrochloride capsules, USP with a full glass of liquid. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
  • Minocycline hydrochloride capsules, USP may be taken with or without food. If you forget to take minocycline hydrochloride capsules, USP, take them as soon as you remember.
  • If you take too much minocycline hydrochloride capsules, USP, call your doctor or poison control center right away.

What are the possible side effects of minocycline hydrochloride capsules, USP?
Minocycline hydrochloride capsules, USP may cause serious side effects. Stop minocycline hydrochloride capsules, USP and call your doctor if you have:

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

Minocycline hydrochloride capsules, USP may also cause:

  • central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms.
  • sun sensitivity (photosensitivity). You may get a worse sunburn with minocycline hydrochloride capsules, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride capsules, USP and call your doctor if your skin turns red.

These are not all the side effects with minocycline hydrochloride capsules, USP. Ask your doctor or pharmacist for more information.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store minocycline hydrochloride capsules, USP?

  • Store minocycline hydrochloride capsules, USP at room temperature and away from excess heat and moisture.
  • Throw away any minocycline hydrochloride capsules, USP that are outdated or no longer needed.
  • Keep minocycline hydrochloride capsules, USP and all medicines out of the reach of children.

General advice about minocycline hydrochloride capsules, USP
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about minocycline hydrochloride capsules, USP.

If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about minocycline hydrochloride capsules, USP that is written for health care professionals. For more information, you can also call Torrent Pharmaceuticals Inc. at 1-800-912-9561.

What are the ingredients in minocycline hydrochloride capsules, USP?

Active ingredient: minocycline hydrochloride, USP, 50 mg, 75 mg and 100 mg

Inactive ingredients: Corn starch and magnesium stearate.

The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide.

The 75 mg and 100 mg capsule shells also contain black iron oxide.

The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.

This Patient information has been approved by the U.S. Food and Drug Administration.

Trademarks are the property of their respective owners.

Distributed by:
American Health Packaging Columbus, OH 43217

8433665/0722

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