Viokace

Name: Viokace

Viokace Overview

Viokace is a brand name medication. For more information about Viokace see its generic Pancrelipase

How should I take pancrelipase?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Do not switch brands of this medicine without your doctor's advice.

Pancrelipase should be taken with a meal or snack.

Read all patient information, medication guides, and instruction sheets provided to you. Be especially careful to follow all directions about giving this medicine to a child. Ask your doctor or pharmacist if you have any questions.

Pancrelipase is sometimes given with a stomach acid reducer such as Nexium, Prevacid, Prilosec, or Protonix. Follow your doctor's instructions about taking all medicines needed to treat your condition.

Do not crush, chew, or break a pancrelipase capsule or tablet. Swallow it whole with a full glass of water.

Do not hold the pill in your mouth. Pancrelipase can irritate the inside of your mouth.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow the mixture right away without chewing. Do not save for later use. Do not mix the medicine with infant formula or breast milk.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature, away from moisture and heat. Keep the medicine container tightly closed.

Your medicine bottle may also include a packet or canister of moisture-absorbing preservative. Keep this packet in the bottle at all times.

Call your doctor if you have any worsening of a long-term pancreas problem.

What happens if I miss a dose?

Take the missed dose with your next meal or snack. Do not take extra medicine to make up the missed dose.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Uses For Viokace

Pancrelipase is used to help improve food digestion in certain conditions (eg, cystic fibrosis, pancreatitis) where the pancreas is not working properly. Pancrelipase contains the enzymes (including lipases, proteases, and amylases) needed for the digestion of proteins, starches, and fats.

This medicine is available only with your doctor's prescription.

Proper Use of pancrelipase

This section provides information on the proper use of a number of products that contain pancrelipase. It may not be specific to Viokace. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor about anything you do not understand.

Take this medicine with meals or snacks and enough liquid to swallow it completely, unless otherwise directed by your doctor.

When prescribing this medicine for your condition, your doctor may also prescribe a personal diet for you. Follow the special diet carefully. This is necessary for the medicine to work properly. It is also important to drink plenty of water while you are on this medicine.

For patients taking the tablets:

  • Viokace™ tablet is used in combination with certain medicines for stomach ulcer called proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, Nexium®, Prevacid®, Prilosec®).
  • Swallow the tablets quickly with some liquid, without chewing, to avoid mouth irritation.

For patients taking the delayed-release capsules:

  • Swallow the capsule whole.
  • Do not crush, break, or chew before swallowing. Do not hold the capsule in your mouth.
  • When given to adults or children who can not swallow the capsule, the capsule may be opened and sprinkled on a small amount (about 10 mL or less) of soft food with a pH of 4.5 or less that can be swallowed without chewing, such as applesauce. This mixture must be swallowed immediately and followed with a glass of water or juice. This will ensure complete swallowing of the contents of the capsule and avoid mouth irritation.
  • When given to infants, the contents of the capsule may be put directly into the infant's mouth or mixed with a small amount (about 10 mL or less) of soft acidic food with a pH of 4.5 or less, including applesauce, pureed bananas, or pears, followed by 120 mL of formula or breastfeeding. Do not mix the contents of the capsule directly to alkaline foods, such as milk, breast milk, formula, or ice cream. This could reduce the effect of the medicine.
  • Pertzye® capsules may also be given through a gastrostomy tube with a diameter of 14 French or larger.
    • Mix the contents of the capsule with soft foods (including applesauce).
    • Remove the plunger and carefully spoon the mixture into the syringe. Replace the plunger partially back.
    • Connect the syringe into the tube feeding port and inject the medicine for 10 to 12 seconds.
    • Flush the tube with 10 mL of water to rinse all of the medicine into the stomach.
  • Throw away any unused portions of the mixture. Do not save for later use.

Do not change the brands or dosage forms of pancrelipase without first checking with your doctor. Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • To help digestion:
    • For oral dosage form (capsules):
      • Older adults, adults, and teenagers—One to three capsules before or with meals and snacks. Your doctor may adjust your dose if needed.
      • Children—The contents of one to three capsules sprinkled on food at each meal. Your doctor may adjust your dose if needed.
    • For oral dosage form (delayed-release capsules):
      • Older adults, adults, and children older than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
      • Children older than 12 months and younger than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 1000 lipase units per kg of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
      • Children up to 12 months old—
        • Creon®: 3000 lipase units per 120 milliliters (mL) of infant formula or per breastfeeding.
        • Pancreaze®: 2600 lipase units per 120 mL of infant formula or per breastfeeding.
        • Pertzye®: 4000 lipase units (1 capsule) per 120 mL of infant formula or per breastfeeding.
        • Ultresa™: Use and dose must be determined by your doctor.
        • Zenpep®: 3000 lipase units per 120 mL of infant formula or per breastfeeding.
    • For oral dosage form (powder):
      • Older adults, adults, and teenagers—1/4 teaspoonful (0.7 gram) with meals and snacks. Your doctor may adjust your dose if needed.
      • Children—1/4 teaspoonful with meals. Your doctor may adjust your dose if needed.
    • For oral dosage form (tablets):
      • Older adults, adults, and teenagers—
        • Viokace™: Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
        • One to three tablets before or with meals and snacks. Your doctor may adjust your dose if needed.
      • Children—
        • Viokace™: Use and dose must be determined by your doctor.
        • One to two tablets with meals.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store Creon® capsules at room temperature for 30 days. Throw away any unused medicine after 30 days.

Store the delayed-release capsules in a tightly-closed container to protect them from moisture.

How is this medicine (Viokace) best taken?

Use Viokace as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with meals and snacks.
  • Swallow whole. Do not chew, crush, or hold this product in your mouth. If you do, you may get mouth irritation or it may change the way this medicine works. Talk with your doctor.
  • Take each dose with lots of fluids to make sure you swallow all of the contents.
  • To gain the most benefit, do not miss doses.
  • Keep taking Viokace as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Joint pain or swelling.
  • Mouth or tongue irritation.
  • This medicine may raise the chance of a rare bowel problem called fibrosing colonopathy. This bowel problem can be very bad and may lead to the need for surgery. Call your doctor right away if you have any abnormal or very bad stomach pain, bloating, trouble passing stools, upset stomach, throwing up, or loose stools (diarrhea).

Clinical Studies

The short-term safety and efficacy of Viokace were evaluated in a randomized, double-blind, placebo-controlled, parallel group study comparing Viokace Tablets (20,880 USP units of lipase per tablet) to placebo in 50 patients, ages 24 to 70, with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with Viokace). All patients were maintained on a controlled high fat diet of 100 grams of fat per day. After a wash-out period (6 to 7 days), patients were randomized to a fixed dose of Viokace (22 tablets per day; 6 tablets per meal and 2 tablets with 2 of 3 snacks) or placebo, in combination with a proton pump inhibitor. Forty-nine patients completed the double-blind treatment period (6 to 7 days); 29 patients received Viokace, and 20 patients received placebo.

The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.

The wash-out period mean CFA was 48% in the Viokace treatment group and was 57% in the placebo group. At the end of the double-blind treatment period, the mean CFA was 86% with Viokace treatment compared to 58% with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of Viokace treatment with 95% Confidence Interval of (21, 37) and p ≤ 0.0001.

Subgroup analyses of the CFA results showed that mean change in CFA with Viokace treatment (from the washout period to the end of the double-blind period) was greater in patients with lower wash-out period CFA values than in patients with higher wash-out period CFA values.

Only 2 of the patients with a history of total pancreatectomy were treated with Viokace. One of these patients had a CFA of 12% during the wash-out period and a CFA of 90% at the end of the double-blind period; the other patient had a CFA of 38% during the wash-out period and a CFA of 77% at the end of the double-blind period. The remaining 9 patients with a history of partial pancreatectomy treated with Viokace had a mean CFA of 56% during the wash-out period and a mean CFA of 86% at the end of the double-blind period.

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