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Cellulose and Citric Acid

Medically reviewed by Drugs.com. Last updated on July 26, 2020.

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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>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.

Reproductive Considerations

Medications for weight loss therapy are not recommended at conception (ACOG 156 2015; Stang 2016).

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 during pregnancy (ACOG 156 2015; Stang 2016). Use of this product is contraindicated in pregnant females.

Patient Education

What is this drug used for?

• It is used to help you lose weight.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bloating

• Abdominal pain

• Diarrhea

• Constipation

• Passing gas

• Nausea

• Stuffy nose

• Sore throat

• Headache

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:

• Low blood sugar like dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating.

• 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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

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