Medigel

Each tablet contains 1g of Medigel.

Medigel is a white, amorphous powder which is soluble in strong acids and alkalis but practically insoluble in water and in alcohol. It is a basic, aluminum complex of sucrose octasulfate.

Medigel is α-D-glucopyranoside, β-D-fructofuranosyl, octakis (hydrogen sulfate), aluminum complex. Its molecular formula is C₁₂H_mAl₁₆O_nS₈ (_m and _n are approximately 54 and 75, respectively, resulting in an average molecular weight of about 2086 daltons).

Medigel tablets, USP are indicated in:

Medigel is used to treat and prevent duodenal ulcers. Medigel may also be used for other conditions as determined by your doctor.

Medigel works by forming a ``barrier'' or ``coating'' over the ulcer. This protects the ulcer from the acid of the stomach, allowing it to heal. Medigel contains an aluminum salt.

Medigel is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Medigel is used in certain patients with the following medical conditions:

• Gastric ulcers
• Gastroesophageal reflux disease (a condition in which stomach acid washes back into the esophagus)
• Stomach or intestinal ulcers resulting from stress or trauma damage or from damage caused by medication used to treat rheumatoid arthritis

Usual Adult Dose for Duodenal Ulcer

1 g orally on an empty stomach 4 times a day or alternatively,

2 g orally on an empty stomach 2 times a day.

Usual Adult Dose for Duodenal Ulcer Prophylaxis

1 g orally on an empty stomach twice a day.

Usual Adult Dose for Gastric Ulcer

1 g orally on an empty stomach 4 times a day.

Usual Adult Dose for Gastroesophageal Reflux Disease

1 g orally on an empty stomach 4 times a day.

Usual Adult Dose for Stress Ulcer Prophylaxis

1 g orally on an empty stomach every 4 to 6 hours.

Usual Adult Dose for Stomatitis

1 g (10 mL) topically as a suspension 4 times a day.

Usual Adult Dose for Hyperphosphatemia of Renal Failure

1 g orally on an empty stomach twice a day.

This dose may be titrated based on serum phosphate levels.

Usual Pediatric Dose for Stomatitis

Safety and effectiveness of Medigel in pediatric patients have not been established. However, the use of Medigel may be appropriate in some situations.

Greater than 1 year: 250 to 500 mg (2.5 to 5 mL) topically as a suspension 4 times a day for treatment of stomatitis.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

While short-term therapy with Medigel can result in complete healing of a duodenal ulcer, a successful course of treatment with Medigel should not be expected to alter the posthealing frequency or severity of duodenal ulceration.

When Medigel is given orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of Medigel with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of Medigel and concomitant medications adequately excrete aluminum in the urine. Patients receiving dialysis or those with chronic renal failure have impaired excretion of absorbed aluminum. Further, aluminum does not cross dialysis membranes because it is bound to albumin and transferring plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Medigel should be used with caution in patients with chronic renal failure.

In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Medigel is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because the elderly are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Dialysis

Data not available

Other Comments

Therapy should be continued approximately 4 to 8 weeks depending on disease and severity.

See also:
What is the most important information I should know about Medigel?

Before taking Medigel, tell your doctor if you have diabetes, kidney disease, or if you are on dialysis.

Take Medigel on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the ulcer is completely healed.

Avoid taking any other medications within 2 hours before or after you take Medigel. Medigel can make it harder for your body to absorb other medications you take by mouth.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for Medigel to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking Medigel.

Use Medigel suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Medigel suspension by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. If you are unsure of how to measure your dose, ask your doctor or pharmacist for help.
• Medigel suspension should only be taken by mouth. Do NOT inject Medigel suspension.
• Do not take an antacid for at least 30 minutes before or after taking Medigel suspension.
• It may take 4 to 8 weeks for complete healing of your ulcer. Continue taking Medigel suspension for the full course of treatment even if you feel better.
• Do not take Medigel suspension at the same time as other medicines. Take Medigel suspension at least 2 hours after other medicines. If you are not sure about the best time to take Medigel suspension, ask your doctor or pharmacist.
• If you miss a dose of Medigel suspension, take it as soon as possible. If it is almost time for your next dose, go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Medigel suspension.

Medigel is used to treat stomach ulcers, bowel ulcers and inflammation of the stomach.

See also:
What other drugs will affect Medigel?

Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Avoid combination

Bictegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Bictegravir. Management: Administer bictegravir under fasting conditions at least 2 hours before or 6 hours after polyvalent cation containing products. Coadministration of bictegravir with or 2 hours after most polyvalent cation products is not recommended. Consider therapy modification

Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Consider therapy modification

Cholic Acid: Medigel may decrease the absorption of Cholic Acid. Consider therapy modification

Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Consider therapy modification

Digoxin: Medigel may decrease the serum concentration of Digoxin. Specifically, Medigel may decrease the absorption of digoxin. Management: Administer digoxin at least 2 hours before Medigel. Consider therapy modification

Dolutegravir: Medigel may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after Medigel. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after Medigel. Consider therapy modification

Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Consider therapy modification

Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Consider therapy modification

Furosemide: Medigel may decrease the serum concentration of Furosemide. Medigel may impair the absorption of furosemide. Management: Avoid concomitant oral administration of furosemide and Medigel. Separate administration by at least 2 hours. Does not apply to parenterally administered furosemide. Consider therapy modification

Ketoconazole (Systemic): Medigel may decrease the serum concentration of Ketoconazole (Systemic). Monitor therapy

Levothyroxine: Medigel may decrease the serum concentration of Levothyroxine. Monitor therapy

Multivitamins/Fluoride (with ADE): May increase the serum concentration of Medigel. Specifically, the absorption of aluminum may be increased. Medigel may decrease the serum concentration of Multivitamins/Fluoride (with ADE). More specifically, Medigel may impair the absorption of fluoride. Management: Avoid administration of aluminum-containing products, such as Medigel, within at least 1-2 hours of fluoride administration. In patients with severe renal dysfunction, consider avoiding this combination altogether. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May increase the serum concentration of Medigel. Specifically, the absorption of aluminum from Medigel may be increased, leading to an increase in the serum aluminum concentration. Avoid combination

PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Consider therapy modification

Phosphate Supplements: Medigel may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate administration. Administering oral phosphate supplements at least 2 hours before Medigel may reduce the significance of the interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification

QuiNIDine: Medigel may decrease the serum concentration of QuiNIDine. Specifically, Medigel may decrease the absorption of quinidine. Management: Administer quinidine at least 2 hours before Medigel. Consider therapy modification

Quinolones: Medigel may decrease the serum concentration of Quinolones. Management: Avoid concurrent administration of quinolones and Medigel to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Raltegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction. Consider therapy modification

Sulpiride: Medigel may decrease the serum concentration of Sulpiride. Management: Separate administration of Medigel and sulpiride by at least 2 hours in order to minimize the impact of Medigel on sulpiride absorption. Consider therapy modification

Tetracyclines: Medigel may decrease the absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to Medigel in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to Medigel. Exceptions: Eravacycline. Consider therapy modification

Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant administration of trientine and oral products that contain polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. If other oral polyvalent cations are needed, separate administration by 1 hour. Consider therapy modification

Vitamin D Analogs: May increase the serum concentration of Medigel. Specifically, the absorption of aluminum from Medigel may be increased, leading to an increase in the serum aluminum concentration. Avoid combination

Vitamin K Antagonists (eg, warfarin): Medigel may diminish the anticoagulant effect of Vitamin K Antagonists. Medigel may decrease the serum concentration of Vitamin K Antagonists. Specifically, Medigel may decrease the absorption of Vitamin K Antagonists. Management: Administer vitamin K antagonists at least 2 hours before Medigel. Consider therapy modification

See also:
What are the possible side effects of Medigel?

Adverse reactions to Medigel tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Medigel, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting.

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Medigel tablets. Similar events were reported with Medigel Suspension. However, a causal relationship has not been established. Cases of hyperglycemia have been reported with Medigel.

Bezoars have been reported in patients treated with Medigel. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble Medigel and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Medigel is not intended for intravenous administration.