Minocycline Hydrochloride (Page 4 of 5)

HOW SUPPLIED

Minocycline hydrochloride Capsules USP, 50 mg are Flesh Opaque/ Flesh Opaque colored hard gelatin capsules, imprinted with ‘851’ on both cap and body in black ink available as follows:


Bottles of 100 NDC 57664-851-88

Bottles of 500 NDC 57664-851-13

Minocycline hydrochloride Capsules USP, 75 mg are Gray Opaque/Gray Opaque colored hard gelatin capsules, imprinted with ‘852’ on both cap and body in black ink available as follows:

Bottles of 100 NDC 57664-852-88

Bottles of 500 NDC 57664-852-13

Minocycline hydrochloride Capsules USP, 100 mg are Maroon Opaque/ Flesh Opaque colored hard gelatin capsules, imprinted with ‘853’ on both cap and body in black ink available as follows:

Bottles of 50 NDC 57664-853-85

Bottles of 500 NDC 57664-853-13

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Protect from light, moisture and excessive heat.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

ANIMAL PHARMACOLOGY AND TOXICOLOGY


Minocycline hydrochloride, USP has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and mon‑keys). In the rat, chronic treatment with minocycline hydrochloride has result‑ed 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.

This product’s label may have been updated. For current package insert and further product information, please call Sun Pharmaceutical Industries, Inc. by calling at 1-800-818-4555.

Manufactured by:

Sidmak Laboratories (India) Pvt. Ltd.

Plot No. 20, Pharma City, Selaqui Industrial Area

Dehradun, 248197, Uttarakhand, India.

P2081004

M. L. No.: 41/UA/SC/P-2007

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512 USA

6235T03

Rev. 03/18

PATIENT INFORMATION


PATIENT INFORMATION

Minocycline Hydrochloride Capsules, USP
(mye-no-SYE-kleen) Hydrochloride Capsules

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 hydrochlo‑ride 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:
o
Decrease the effectiveness of the treatment
o
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 many 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 hydrochlo‑ride 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 healthcare professionals. For more information, you can also contact Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555.

What are the ingredients in Minocycline Hydrochloride Capsules, USP?

Each minocycline hydrochloride capsules, USP contains minocycline hydrochloride USP equivalent to 50 mg, 75 mg or 100 mg Minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide.

All product/brand names are trademarks of their respective owners.

P2081004
M.L. NO.: 41/UA/SC/P-2007

Manufactured by:

Sidmak Laboratories India Pvt. Ltd.
Plot No. 20, Pharma City, Selaqui Industrial Area
Dehradun, 248197, Uttarakhand, India

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

6235T03

Rev. 03/18

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