ITRACONAZOLE (Page 5 of 5)

OVERDOSAGE


Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Contact a certified poison control center for the most up to date information on the management of itraconazole capsules overdosage (1-800-222-1222 or www.poison.org).

In general, adverse events reported with overdose have been consistent with adverse drug reactions already listed in this package insert for itraconazole. (See ADVERSE REACTIONS.)

DOSAGE AND ADMINISTRATION

Itraconazole capsules should be taken with a full meal to ensure maximal absorption. Itraconazole capsules must be swallowed whole.

Itraconazole capsule is a different preparation than itraconazole Oral Solution and should not be used interchangeably.

Treatment of Blastomycosis and Histoplasmosis:

The recommended dose is 200 mg once daily (2 capsules). If there is no obvious improvement, or there is evidence of progressive fungal disease, the dose should be increased in 100-mg increments to a maximum of 400 mg daily. Doses above 200 mg/day should be given in two divided doses.

Treatment of Aspergillosis:

A daily dose of 200 to 400 mg is recommended.

Treatment in Life-Threatening Situations:

In life-threatening situations, a loading dose should be used.

Although clinical studies did not provide for a loading dose, it is recommended, based on pharmacokinetic data, that a loading dose of 200 mg (2 capsules) three times daily (600 mg/day) be given for the first 3 days of treatment.

Treatment should be continued for a minimum of three months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.

Itraconazole capsules and itraconazole Oral Solution should not be used interchangeably. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Treatment of Onychomycosis:

Toenails with or without fingernail involvement: The recommended dose is 200 mg (2 capsules) once daily for 12 consecutive weeks.

Treatment of Onychomycosis:

Fingernails only: The recommended dosing regimen is two treatment pulses, each consisting of 200 mg (2 capsules) b.i.d. (400 mg/day) for 1 week. The pulses are separated by a 3-week period without itraconazole.

Use in Patients with Renal Impairment:

Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population. (See CLINICAL PHARMACOLOGY: Special Populations and PRECAUTIONS .)

Use in Patients with Hepatic Impairment:

Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and PRECAUTIONS.)

HOW SUPPLIED

Itraconazole capsules are supplied as follows:

100 mg:

Blue opaque cap/pink transparent body size “0” hard gelatin capsules having imprinting “A” on cap with black ink and “175” on body with black ink filled with white to off-white pellets.

NDC: 70518-3264-00

PACKAGING: 14 in 1 BOTTLE PLASTIC

Store at controlled room temperature 15° to 25°C (59° to 77°F). Protect from light and moisture.

Keep out of reach of children.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PATIENT INFORMATION

Itraconazole (IT-ra-KON-a-zole) Capsules Rx Only

Read this Patient Information that comes with itraconazole capsules before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about itraconazole capsules? Itraconazole capsules can cause serious side effects, including:

1. Heart failure. Do not take itraconazole capsules if you have had heart failure, including congestive heart failure.

Stop taking itraconazole capsules and call your healthcare provider right away if you have any of these symptoms of congestive heart failure:

2. Heart problems and other serious medical problems. Serious medical problems that affect the heart and other parts of your body can happen if you take itraconazole capsules with certain other medicines. Do not take itraconazole capsules if you also take the following medicines:

shortness of breath coughing up white or pink mucus (phlegm)
swelling of your feet, ankles or legs fast heartbeat
sudden weight gain waking up at night more than normal for you
increased tiredness

This is not a complete list of medicines that can interact with itraconazole capsules. Itraconazole capsules may affect the way other medicines work, and other medicines may affect how itraconazole capsules works. You can ask your pharmacist for a list of medicines that interact with itraconazole capsules.

Before you start taking itraconazole capsules, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start any new medicine, ask your healthcare provider or pharmacist if it is safe to take it with itraconazole capsules.

3. Liver problems. Itraconazole capsules can cause serious liver problems which may be severe and lead to death. Stop taking itraconazole capsules and call your healthcare provider right away if you have any of these symptoms of liver problems:

• Methadone •methylergometrine (methylergonovine) • ranolazine
•disopyramide • irinotecan • eplerenone
• dofetilide • irinotecan • cisapride
• dronedarone • lurasidone • naloxegol
• quinidine • oral midazolam • lomitapide
•isavuconazole • pimozide • lovastatin
•ergot alkaloids (such as dihydroergotamine, ergometrine ergonovine) • triazolam • simvastatin
• nisoldipine • ticagrelor
•ergotamine •ivabradine

For more information about side effects, see “ What are the possible side effects of itraconazole capsules?

What is itraconazole capsule?

  • Itraconazole capsule is a prescription medicine used to treat the following fungal infections of the toenails, fingernails and other parts of the body: blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
  • It is not known if itraconazole capsule is safe and effective in children.

Do not take itraconazole capsule if you:

  • have or have had heart failure, including congestive heart failure.
  • take certain medicines. See “ What is the most important information I should know about itraconazole capsules?
  • are pregnant or plan to become pregnant. Itraconazole capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking itraconazole capsules. Females who are able to become pregnant must use effective forms of birth control during treatment and for 2 months after stopping treatment with itraconazole capsules.
  • are allergic to itraconazole or any of the ingredients in itraconazole capsules. See the end of this Patient Information leaflet for a complete list of ingredients in itraconazole capsules.

Before taking itraconazole capsules, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have liver problems.
  • have kidney problems.
  • have a weakened immune system (immunocompromised).
  • have lung problems including cystic fibrosis.
  • are breastfeeding or plan to breastfeed. Itraconazole can pass into your breast milk. You and your healthcare provider should decide if you will take itraconazole capsules or breastfeed.

Taking itraconazole capsules with certain medicines may affect each other. Taking itraconazole capsules with other medicines can cause serious side effects.

How should I take itraconazole capsules?

  • Take itraconazole capsules exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much itraconazole capsules to take and when to take it.
  • You will receive itraconazole capsules in a blister pack, bottle or 7 Day Treatment Pack. Your healthcare provider will decide the type of itraconazole capsules that is right for you.
  • Take itraconazole capsules with a full meal.
  • Swallow itraconazole capsules whole.
  • You should not take itraconazole oral solution instead of itraconazole capsules, because they will not work the same way.
  • If you take too much itraconazole capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking itraconazole capsules?

Itraconazole capsules can cause dizziness and vision problems. Do not drive or operate machinery until you know how itraconazole capsule affects you.

What are the possible side effects of itraconazole capsules?

Itraconazole capsules may cause serious side effects, including:

  • See “What is the most important information I should know about itraconazole capsules?”
  • Nerve problems (neuropathy). Call your healthcare provider right away if you have tingling or numbness in your hands or feet. Your healthcare provider may stop your treatment with itraconazole capsules if you have nerve problems.
  • Hearing loss. Hearing loss can happen for a short time or permanently in some people who take itraconazole capsules. Stop taking itraconazole capsules and call your healthcare provider right away if you have any changes in your hearing.

The most common side effects of itraconazole capsules include: headache, rash, and digestive system problems (such as nausea and vomiting). Additional possible side effects include upset stomach, vomiting, constipation, fever, inflammation of the pancreas, menstrual disorder, erectile dysfunction, dizziness, muscle pain, painful joints, unpleasant taste, or hair loss.

These are not all the possible side effects of itraconazole capsules.

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 itraconazole capsules?

  • Store itraconazole capsules at room temperature between 15° to 25°C (59° to 77°F).
  • Keep itraconazole capsules dry and away from light.

Keep itraconazole capsules and all medicines out of the reach of children.

General information about the safe and effective use of itraconazole capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use itraconazole capsules for a condition for which it was not prescribed. Do not give itraconazole capsules to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about itraconazole capsules that is written for health professionals.

What are the ingredients in itraconazole capsules?

Active ingredients: itraconazole (coated on sugar spheres composed of sucrose, starch and purified water)

Inactive ingredients: hydroxypropyl methylcellulose, polyethylene glycol, gelatin, titanium dioxide, D&C Red No. 22, FD&C Blue No. 1, and D&C Red No. 28. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

• tiredness •your skin or the white part of your eyes turn yellow (jaundice)
•loss of appetite for several days or longer •light-colored stools (bowel movement)
•nausea or vomiting
•dark or “tea-colored” urine

DRUG: ITRACONAZOLE

GENERIC: itraconazole

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-3264-0

COLOR: blue

SHAPE: CAPSULE

SCORE: No score

SIZE: 21 mm

IMPRINT: A;175

PACKAGING: 14 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • ITRACONAZOLE 100mg in 1

INACTIVE INGREDIENT(S):

  • SUCROSE
  • HYPROMELLOSE, UNSPECIFIED
  • POLYETHYLENE GLYCOL 20000
  • TITANIUM DIOXIDE
  • D&C RED NO. 22
  • FD&C BLUE NO. 1
  • D&C RED NO. 28
  • GELATIN
  • STARCH, CORN
  • SHELLAC
  • FERROSOFERRIC OXIDE
  • POTASSIUM HYDROXIDE
Remedy_Label
(click image for full-size original)
ITRACONAZOLE itraconazole capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-3264(NDC:62332-204)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ITRACONAZOLE (ITRACONAZOLE) ITRACONAZOLE 100 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 20000
TITANIUM DIOXIDE
D&C RED NO. 22
FD&C BLUE NO. 1
D&C RED NO. 28
GELATIN
STARCH, CORN
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color blue (blue opaque pink transparent) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code A;175
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-3264-0 14 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206741 11/08/2021
Labeler — REMEDYREPACK INC. (829572556)

Revised: 11/2021 REMEDYREPACK INC.

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