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Cellulose and Citric Acid

Medically reviewed by Drugs.com. Last updated on Apr 29, 2019.

Pronunciation

(SEL yoo lose & SIT rik AS id)

Index Terms

  • Citric Acid and Cellulose
  • Plenity

Pharmacologic Category

  • Gastrointestinal Agent, Miscellaneous

Pharmacology

Cellulose and citric acid form a three-dimensional matrix that occupies volume in the stomach and small intestine to create a sensation of fullness and increase satiety.

Absorption

Oral: Not systemically absorbed

Onset of Action

Oral: Satiety: 20 to 30 minutes

Use: Labeled Indications

Weight management: Management of weight in overweight and obese adults with a BMI of 25 to 40 kg/m2, when used in conjunction with diet and exercise.

Contraindications

Hypersensitivity to cellulose, citric acid, sodium stearyl fumarate, gelatin, titanium oxide, or any component of the formulation; pregnancy.

Dosing: Adult

Weight management: Oral: 2.25 g (3 capsules) twice daily (before lunch and dinner).

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral: Administer capsules with water 20 to 30 minutes before lunch and dinner. Following administration, immediately consume an additional 16 ounces of water. If a premeal dose is missed, may be administered during or immediately after the meal.

Storage

Store in original blister packs at 5°C to 30°C (41°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Gastrointestinal: GI adverse effects (38%), diarrhea (13%), abdominal distention (12%)

1% to 10%:

Gastrointestinal: Change in bowel habits (infrequent: 9%), flatulence (9%), abdominal pain (5%)

Warnings/Precautions

Concerns related to adverse effects:

• GI: Severe abdominal pain or diarrhea may occur; discontinue use.

Disease-related concerns:

• Dysphagia: Use with caution in patients with dysphagia; may affect ability to swallow capsules.

• GI disease: Use with caution in patients with active GI disease, such as gastroesophageal reflux disease, heartburn, or ulcers. Avoid use in patients with esophageal anatomic anomalies (eg, diverticuli, rings, webs), suspected strictures (eg, Crohn disease), and complications from prior GI surgery that may affect mobility and transit.

Concurrent drug therapy issues:

• Altered medication absorption: May affect absorption of other medications; monitor for safety and effectiveness. Avoid concurrent administration when possible. For oral medications scheduled to be administered at lunch or dinner, the manufacturer's labeling recommends administering the concomitant medication after the meal has started.

Dosage form specific issues:

• Packaging: Do not use if blister package is damaged or capsules are broken, crushed, or damaged.

Other warnings/precautions:

• Appropriate use: Should be taken under supervision of a health care provider as part of a structured weight loss program. Not a food substitute.

Monitoring Parameters

BMI; weight; blood glucose in diabetic patients.

Pregnancy Considerations

The cellulose and citric acid matrix contained in Plenity capsules are not systemically absorbed.

An increased risk of adverse maternal and fetal outcomes is associated with obesity. However, moderate weight gain based on prepregnancy BMI is required for positive fetal outcomes. Therefore, medications for weight loss therapy are not recommended at conception or during pregnancy (ACOG 156 2015; Stang 2016). Use of this product is contraindicated in pregnant females.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience bloating, abdominal pain, diarrhea, constipation, flatulence, nausea, rhinitis, pharyngitis, or headache. Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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