VP-Precip description, usages, side effects, indications, overdosage, supplying and lots more!

VP-Precip

Virtus Pharmaceuticals LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
VP-PRECIP

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

120 Softgels
76439-232-12
Dispense by Prescription

DESCRIPTION: VP-PRECIP is an orally administered medical food specifically formulated for the dietary management of patients with unique nutritional needs associated with dry eye syndrome, blepharitis, and meibomian gland dysfunction.

VP-PRECIP should be administered under the supervision of a licensed medical practitioner.

Contains the following dietary ingredients:

Flaxseed Oil 1000 mg
Evening Primrose Oil 500 mg
Bilberry Extract 40 mg

Other Ingredients: Caramel, Ethyl Vanillin, Gelatin (bovine), Glycerin, Purified Water, Soy Lecithin, Vitamin E, and Yellow Beeswax

This product contains soy.

Since colors, flavors of natural origin vary from batch to batch in consistency - it may be necessary to substitute excipients as needed to ensure the highest therapeutic target, safety and quality.

Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.

Uses

INDICATIONS AND USAGE: VP-PRECIP is indicated for the distinctive nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. VP-PRECIP should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

This product contains evening primrose oil, which may increase risk of pregnancy complications. This product is contraindicated in pregnant women.

Studies of evening primrose oil showed an association with seizures, and thus, it historically has been contraindicated in individuals taking phenothiazines due to its potential to lower seizure threshold and precipitate seizures.

WARNINGS: Flaxseed oil may increase stool bulk and frequency. Caution is advised in individuals with irritable bowel syndrome (IBS), bowel obstruction, and/or diverticular disease.

Flaxseed oil may cause ileus (intestinal blockage).

Flaxseed oil may cause a thyroid problem.

Flaxseed oil and evening primrose oil may slow blood clotting. Individuals with blood disorders or those taking blood thinning medications, such as aspirin, should consult their medical practitioner before taking this product. Blood clotting times may need to be evaluated.

Safety and effectiveness in children have not been established.

Avoid taking at the same time with other medications, medical foods, and/or supplements.

Please see product ingredients. Consult your healthcare practitioner or pharmacist for more information.

PATIENT INFORMATION: VP-PRECIP is a medical food to be used only under licensed medical supervision.

DRUG INTERACTIONS:

Drugs which may interact with flaxseed oil include:

  • Flaxseed oil may act as a blood thinner. Consult your healthcare practitioner before taking if already using blood thinning medications, such as anticoagulant and antiplatelet drugs.

Drugs which may interact with evening primrose oil include:

  • Evening primrose oil may interact with phenothiazines and increase the incidence of seizure.
  • Evening primrose oil may act as a blood thinner. Consult your healthcare practitioner before taking if already using blood thinning medications, such as anticoagulant and antiplatelet drugs.

Drugs which may interact with bilberry include:

  • Bilberry has been shown to reduce blood sugar levels. Taking bilberry along with diabetes medications may lower blood sugar levels to dangerous levels.

PREGNANCY and NURSING MOTHERS: Pregnancy Category C: It is not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction. However, this product is contraindicated in pregnant women due to increased risk of pregnancy complications (see Contraindications). Consult your healthcare practitioner before taking if breastfeeding.

ADVERSE REACTIONS: Allergic sensitization is possible in susceptible individuals. Generally well-tolerated if taken in normal amounts. Flaxseed oil increases stool bulk and defecation frequency. If breathing problems, tightness in the throat and/or chest, chest pain, skin hives, rash, itchy or swollen skin, headache, GI upset, or nausea occur, immediately discontinue use and consult your healthcare practitioner.

DOSAGE AND ADMINISTRATION: Four (4) softgels daily. May be taken with or without food. Avoid taking at the same time with other medications, medical foods, and/or supplements.

STORAGE: Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

HOW SUPPLIED: VP-PRECIP is supplied as oval, dark brown soft gelatin capsules imprinted with “V232”, dispensed in bottles of 120 softgels.

76439-232-12

*This product is a medical food and requires licensed medical supervision.

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Call your medical practitioner about side effects. You may report side effects by calling (813) 283-1344.

Dispense by Prescription

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

MADE IN CANADA

Rev. 5/2012

PRINCIPAL DISPLAY PANEL - 120 Softgels Bottle Label text

VIRTUS
PHARMACEUTICALS

NDC 76439-232-12

VP-PRECIP

Medical Food

Dispense by Prescription

120 Softgels

PRINCIPAL DISPLAY PANEL - 120 Softgels Bottle Label text

VP-Precip

linseed oil, evening primrose oil and bilberry CAPSULE, GELATIN COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:76439-232
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LINSEED OIL 1000 mg
EVENING PRIMROSE OIL 500 mg
BILBERRY Bilberry 40 mg

Inactive Ingredients

Ingredient Name Strength
CARAMEL
ETHYL VANILLIN
GELATIN
GLYCERIN
water
LECITHIN, SOYBEAN
.ALPHA.-TOCOPHEROL
YELLOW WAX

Product Characteristics

Color Size Imprint Code Shape
BROWN (dark brown) 12 mm V232 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76439-232-12 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-05-18


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