Ximino Capsules

Ximino is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines [see Adverse Reactions (6.2)].

The active ingredient in Ximino Extended-Release Capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Ximino is a tetracycline-class drug. Ximino is known chemically as [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:

Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether.

Ximino (minocycline hydrochloride) Extended-Release Capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The Extended-Release Capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide.

The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc.

Ximino Extended-Release Capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.

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

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.

*Evaluator’s Global Severity Assessment

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

“See FDA-Approved Patient Labeling (Patient Information)”

Patients taking Ximino should receive the following information and instructions:

• Ximino should not be used by pregnant women or women attempting to conceive a child [see Use in Specific Populations (8.1), Nonclinical Toxicology (13.1)].
• It is recommended that Ximino not be used by men who are attempting to father a child [see Nonclinical Toxicology (13.1)].
• Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention
• Patients should be counseled about the possibility of hepatotoxicity. Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness.
• Patients who experience central nervous system symptoms [see Warnings and Precautions (5.5)] should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should seek medical help for persistent headaches or blurred vision.
• Concurrent use of tetracycline may render oral contraceptives less effective. To avoid contraceptive failure, female patients on low dose oral contraceptives should be advised to use a second form of contraception during treatment with minocycline [see Drug Interactions (7.5)].
• Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, 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.
• Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy.
• 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.
• Ximino should be taken 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.
• Patients should be advised to swallow Ximino whole and not to chew, crush, or split the capsules.

FDA-Approved Patient Labeling

PATIENT INFORMATION

XIMINO (Zī-min-ō)

(minocycline hydrochloride)

Extended-Release Capsules

Read this Patient Information leaflet that comes with Ximino 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 talking with your doctor about your condition or treatment.

What is Ximino?

Ximino is a tetracycline-class drug. Ximino is prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older. Ximino is not effective for acne that is not red-looking (this means acne that is not inflammatory).

It is not known if Ximino is:

• safe for use longer than 12 weeks.
• safe and effective for the treatment of infections.
• safe and effective in children under the age of 12 years.

Who should not take Ximino?

Do not take Ximino if you are allergic to tetracycline class medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

What should I tell my doctor before taking Ximino?

Before you take Ximino, tell your doctor if you:

• have kidney problems. Your doctor may prescribe a lower dose of medicine for you
• have liver problems
• have diarrhea or watery stools
• have vision problems
• plan to have surgery with general anesthesia
• have any other medical conditions
• are a male, and you and your female partner are trying to conceive a baby. You should not take Ximino.
• are pregnant or plan to become pregnant. Ximino may harm your unborn baby. Taking Ximino while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking Ximino if you plan to become pregnant, or if you are already taking Ximino and plan to become pregnant. Stop taking Ximino and call your doctor right away if you become pregnant while taking Ximino.
• are breastfeeding or plan to breastfeed. Ximino passes into your milk and may harm your baby. You and your doctor should decide if you will take Ximino or breastfeed. You should not do both.

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

Especially tell your doctor if you take:

• birth control pills. Ximino may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking Ximino.
• a blood thinner medicine.
• a penicillin antibiotic medicine. Ximino and penicillins should not be used together.
• antacids that contain aluminum, calcium, or magnesium or iron-containing products.
• an acne medication that contains isotretinoin. Ximino 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 when you get a new medicine.

How should I take Ximino?

• Take Ximino exactly as your doctor tells you.
• Skipping doses or not taking all doses of Ximino may:
  • make the treatment not work as well.
  • increase the chance that the bacteria will become resistant to Ximino.

• Ximino can be taken with or without food. Taking Ximino 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 Ximino whole. Do not chew, crush, or split the capsules.

If you take too much Ximino, call your doctor or poison control center right away. Your doctor may do blood tests to check you for side effects during treatment with Ximino.

What should I avoid while taking Ximino?

• Avoid sunlight, sunlamps, and tanning beds. Ximino can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn.
• Wear loose-fitting clothes that protect your skin from sun exposure. Talk to your doctor about other ways to protect your skin while out in sunlight.
• You should not drive or operate dangerous machinery until you know how Ximino affects you. Ximino may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).

What are possible side effects of Ximino?

Ximino may cause serious side effects, including:

• Harm to an unborn baby. See “What should I tell my doctor before taking Ximino?”
• Permanent teeth discoloration. Ximino may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Ximino should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See “What should I tell my doctor before taking Ximino?”
• Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including Ximino. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your medication.
• Serious liver problems. Stop taking Ximino and call your doctor right away if you get any of the following symptoms of liver problems:
  • loss of appetite
  • tiredness
  • diarrhea
  • yellowing of your skin or the whites of your eyes
  • unexplained bleeding
  • confusion
  • sleepiness

• Central nervous system effects. See “What should I avoid while taking Ximino?” Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with Ximino or if treatment is stopped. Call your doctor if you get headaches that do not go away or blurred vision.
• Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking Ximino and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.
• Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Using Ximino for a long time to treat acne may cause immune system reactions. Tell your doctor right away if you get a fever, rash, joint pain, or body weakness. Your doctor may do tests to check your blood for immune system reactions.
• Serious rash and allergic reactions. Ximino may cause a serious rash and allergic reactions that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death.
• Stop taking Ximino and get medical help right away if you have any of these symptoms:
  • skin rash, hives, sores in your mouth, or your skin blisters and peels
  • swelling of your face, eyes, lips, tongue, or throat
  • trouble swallowing or breathing
  • blood in your urine
  • fever, yellowing of the skin or the whites of your eyes, dark colored urine
  • pain on the right side of the stomach area (abdominal pain)
  • chest pain or abnormal heartbeats
  • swelling in your legs, ankles and feet
  • darkening of your nails, skin, eyes, scars, teeth, and gums.

The most common side effects of Ximino include:

• headache
• tiredness
• dizziness or spinning feeling
• itching

Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with Ximino.

These are not all the side effects with Ximino. Ask your doctor or pharmacist for more information.

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

How should I store Ximino?

• Store Ximino at room temperature between 68º F to 77º F (20º C to 25º C).
• Keep Ximino in the container that it comes in and keep the container tightly closed.
• Keep Ximino dry.
• Keep Ximino and all medicines out of the reach of children.

General information about Ximino

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Ximino for a condition for which it was not prescribed. Do not give Ximino 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 Ximino. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about Ximino that is written for health professionals.

What are the ingredients in Ximino?

Active Ingredient: minocycline HCl, USP.

Inactive Ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide.

The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc.

Ximino also contains black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.

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

Manufactured for:

Ranbaxy Laboratories Inc.

Jacksonville, FL 32257 USA

by: Ranbaxy Laboratories Ltd.

New Delhi - 110 019, India

Issued July 2012