Albis Uses

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Consists of Ranitidine, sucralfate, tripotassium bismuth dicitrate

What is Ranitidine (Albis)?

Ranitidine (Albis) (Ranitidine (Albis)) belongs to a group of drugs called histamine-2 blockers. Ranitidine (Albis) works by reducing the amount of acid your stomach produces.

Ranitidine (Albis) is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Ranitidine (Albis) also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Ranitidine (Albis) may also be used for other purposes not listed in this medication guide.

Ranitidine (Albis) indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Oral

Benign gastric and duodenal ulceration

Adult: Initially, 300 mg daily at bedtime or 150 mg bid for 4-8 wk; 300 mg bid for 4 wk may be used in duodenal ulcer to improved healing.

Maintenance: 150 mg daily at bedtime. Max: 300 mg bid.

Child: 1 mth to 16 yr 4-8 mg/kg daily in 2 divided doses. Max: 300 mg/day. Treatment duration: 4-8 wk.

Maintenance: 2-4 mg/kg once daily. Max: 150 mg/day.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

H.pylori infection

Adult: 300 mg daily at bedtime or 150 mg bid in combination w/ amoxicillin 750 mg and metronidazole 500 mg tid given for 2 wk. Treatment w/ Ranitidine (Albis) must be continued for a further 2 wk.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

Gastro-oesophageal reflux disease

Adult: 150 mg bid or 300 mg at bedtime for up to 8 wk, may increase to 150 mg 4 times daily for 12 wk in severe cases.

Child: 1 mth to 16 yr 5-10 mg/kg daily in 2 divided doses. Max: 300 mg/day.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

Hypersecretory conditions

Adult: Initially, 150 mg bid or tid and increased if needed. Max: 6 g daily.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

Prophylaxis of acid aspiration during general anaesthesia

Adult: 150 mg given 2 hr before induction of anaesth, and preferably a dose of 150 mg on the previous evening. In obstetric patients at the start of labour, 150 mg may be given, and repeated 6 hrly if required.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

Dyspepsia

Adult: Chronic episodic: 150 mg bid for up to 6 wk. Short-term symptomatic relief: 75 mg repeated if necessary up to 4 doses daily. Max duration: 2 wk of continuous use at one time.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

Erosive oesophagitis

Adult: 150 mg 4 times daily.

Maintenance: 150 mg bid.

Child: 1 mth to 16 yr 5-10 mg/kg daily in 2 divided doses. Max: 600 mg/day.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Oral

NSAID-associated ulceration

Adult: 150 mg bid or 300 mg at bedtime for 8-12 wk. For prevention of NSAID-associated ulceration: 150 mg bid.

Renal impairment:

CrCl (ml/min)Dosage Recommendation
<50150 mg daily at bedtime, adjust dose cautiously if necessary.

Parenteral

Prophylaxis of acid aspiration during general anaesthesia

Adult: 50 mg by IM or slow IV inj 45-60 min before the induction of anaesth.

Renal impairment: Individual doses may be reduced to 25 mg.

Reconstitution: Slow IV inj: Ranitidine (Albis) 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) w/ NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln. Intermittent slow IV infusion: Ranitidine (Albis) 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Continuous IV infusion: Ranitidine (Albis) 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Patients w/ Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine (Albis) should be diluted to a concentration ≤2.5 mg/mL w/ dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Incompatibility: Y-site admin: Amphotericin B cholesteryl sulfate complex, hetastarch in NaCl 0.9%, insulin (regular), pantoprazole. Syringe: Hydroxyzine, methotrimeprazine, midazolam, pantoprazole, pentobarbital, phenobarbital.

Intravenous

Hypersecretory conditions

Adult: Initially, 1 mg/kg/hr, may increase by increments of 0.5 mg/kg/hr beginning after 4 hr if necessary.

Renal impairment: Individual doses may be reduced to 25 mg.

Reconstitution: Slow IV inj: Ranitidine (Albis) 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) w/ NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln. Intermittent slow IV infusion: Ranitidine (Albis) 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Continuous IV infusion: Ranitidine (Albis) 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Patients w/ Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine (Albis) should be diluted to a concentration ≤2.5 mg/mL w/ dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Incompatibility: Y-site admin: Amphotericin B cholesteryl sulfate complex, hetastarch in NaCl 0.9%, insulin (regular), pantoprazole. Syringe: Hydroxyzine, methotrimeprazine, midazolam, pantoprazole, pentobarbital, phenobarbital.

Intravenous

Stress ulceration of upper gastrointestinal tract

Adult: 50 mg by slow IV inj as priming dose followed by 0.125-0.25 mg/kg/hr as continuous IV infusion then transfer to oral dose of 150 mg bid once oral feeding is resumed.

Child: 1 mg/kg (max: 50 mg) as slow IV inj over at least 2 min 6-8 hrly or 0.125-0.25 mg/kg/hr as continuous infusion.

Renal impairment: Individual doses may be reduced to 25 mg.

Reconstitution: Slow IV inj: Ranitidine (Albis) 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) w/ NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln. Intermittent slow IV infusion: Ranitidine (Albis) 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Continuous IV infusion: Ranitidine (Albis) 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Patients w/ Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine (Albis) should be diluted to a concentration ≤2.5 mg/mL w/ dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Incompatibility: Y-site admin: Amphotericin B cholesteryl sulfate complex, hetastarch in NaCl 0.9%, insulin (regular), pantoprazole. Syringe: Hydroxyzine, methotrimeprazine, midazolam, pantoprazole, pentobarbital, phenobarbital.

How should I use Ranitidine (Albis)?

Use Ranitidine (Albis) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • If you are using Ranitidine (Albis) to treat symptoms, take it by mouth with or without food.
  • If you are using Ranitidine (Albis) to prevent symptoms, take it by mouth 30 to 60 minutes before eating food or drinking beverages that cause your symptoms.
  • Take Ranitidine (Albis) with a full glass of water (8 oz/240 mL).
  • If you also take itraconazole or ketoconazole, ask your doctor or pharmacist how to take it with Ranitidine (Albis).
  • Do not take other antacids while you are using Ranitidine (Albis) without first checking with your doctor.
  • Continue to take Ranitidine (Albis) even if you feel well. Do not miss any doses.
  • If you miss a dose of Ranitidine (Albis), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and 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 Ranitidine (Albis).

Uses of Ranitidine (Albis) in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Ranitidine (Albis) is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Ranitidine (Albis) belongs to a class of drugs known as H2 blockers.

This form of Ranitidine (Albis) is given by injection and is used for short-term treatment of these conditions when you cannot take this medication by mouth. Your doctor should switch you to taking this medication by mouth when possible.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent ulcers caused by a certain class of drugs known as nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen). It may also be used to prevent stomach/intestinal bleeding.

How to use Ranitidine (Albis) injection

Read the Patient Information Leaflet if available from your pharmacist before you start using Ranitidine (Albis) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein or muscle as directed by your doctor. Premixed bags should only be given into a vein. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage may also be based on body weight.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition does not improve or if it worsens.

Ranitidine (Albis) description

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Each tablet also contains the following excipients: Tablet Core: Microcrystalline cellulose, magnesium stearate. Film-Coat: Opadry white OY-S-7322, purified water.

Each 10 mL of syrup contains Ranitidine (Albis) 150 mg. It also contains the following excipients: Hydroxypropyl methylcellulose 2906 or 2910 (4000 cP), ethanol (96%), propyl hydroxybenzoate, butyl hydroxybenzoate, potassium dihydrogen orthophosphate, anhydrous disodium hydrogen orthophosphate, sodium chloride, saccharin sodium, sorbitol 70% (non-crystallising), mint flavour IFF 17:42:3632, purified water.

Each 2 mL of ampoule contains Ranitidine (Albis) 50 mg. It also contains the following excipients: Disodium hydrogen orthophosphate, sodium chloride, anhydrous potassium dihydrogen orthophosphate, nitrogen, water for injection.

Ranitidine (Albis) dosage

Parenteral Administration

In some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or in patients who are unable to take oral medication, Ranitidine (Albis) may be administered parenterally according to the following recommendations:

Intramuscular Injection

50 mg (2 mL) every 6 to 8 hours. (No dilution necessary.)

Intermittent

Intravenous Injection

  1. Intermittent Bolus: 50 mg (2 mL) every 6 to 8 hours. Dilute Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection), 50 mg, in 0.9% sodium chloride injection or other compatible IV solution to a concentration no greater than 2.5 mg/mL (20 mL). Inject at a rate no greater than 4 mL/min (5 minutes).
  2. Intermittent Infusion: 50 mg (2 mL) every 6 to 8 hours. Dilute Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection), 50 mg, in 5% dextrose injection or other compatible IV solution to a concentration no greater than 0.5 mg/mL (100 mL). Infuse at a rate no greater than 5 to 7 mL/min (15 to 20 minutes).

Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed solution, 50 mg, in 0.45% sodium chloride, 50 mL, requires no dilution and should be infused over 15 to 20 minutes.

In some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by more frequent administration of the dose, but generally should not exceed 400 mg/day.

Continuous

Intravenous Infusion

Add Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) to 5% dextrose injection or other compatible IV solution. Deliver at a rate of 6.25 mg/hour (e.g., 150 mg [6 mL] of Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) in 250 mL of 5% dextrose injection at 10.7 mL/hour).

For Zollinger-Ellison patients, dilute Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) in 5% dextrose injection or other compatible IV solution to a concentration no greater than 2.5 mg/mL. Start the infusion at a rate of 1.0 mg/kg/hour. If after 4 hours either a measured gastric acid output is > 10 mEq/hour or the patient becomes symptomatic, the dose should be adjusted upward in 0.5-mg/kg/hour increments, and the acid output should be remeasured. Dosages up to 2.5 mg/kg/hour and infusion rates as high as 220 mg/hour have been used.

Pediatric Use

While limited data exist on the administration of IV Ranitidine (Albis) to children, the recommended dose in pediatric patients is for a total daily dose of 2 to 4 mg/kg, to be divided and administered every 6 to 8 hours, up to a maximum of 50 mg given every 6 to 8 hours. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Limited data in neonatal patients (less than 1 month of age) receiving ECMO have shown that a dose of 2 mg/kg is usually sufficient to increase gastric pH to > 4 for at least 15 hours. Therefore, doses of 2 mg/kg given every 12 to 24 hours or as a continuous infusion should be considered.

Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed in Flexible Plastic Containers

Instructions for Use

To Open:Tear outer wrap at notch and remove solution container. Check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

Preparation for Administration: Use aseptic technique.

  1. Close flow control clamp of administration set.
  2. Remove cover from outlet port at bottom of container.
  3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
  4. Suspend container from hanger.
  5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed.
  6. Open flow control clamp to expel air from set. Close clamp.
  7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
  8. Perform venipuncture.
  9. Regulate rate of administration with flow control clamp.
Caution

Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed in flexible plastic containers is to be administered by slow IV drip infusion only. Additives should not be introduced into this solution. If used with a primary IV fluid system, the primary solution should be discontinued during infusion of Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed.

Do not administer unless solution is clear and container is undamaged.

Warning

Do not use flexible plastic container in series connections.

Dosage Adjustment for Patients With Impaired Renal Function

The administration of Ranitidine (Albis) as a continuous infusion has not been evaluated in patients with impaired renal function. On the basis of experience with a group of subjects with severely impaired renal function treated with Ranitidine (Albis), the recommended dosage in patients with a creatinine clearance < 50 mL/min is 50 mg every 18 to 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating Ranitidine (Albis). Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function.

Stability

Undiluted, Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) tends to exhibit a yellow color that may intensify over time without adversely affecting potency. Ranitidine (Albis) Injection is stable for 48 hours at room temperature when added to or diluted with most commonly used IV solutions, e.g., 0.9% sodium chloride injection, 5% dextrose injection, 10% dextrose injection, lactated ringer's injection, or 5% sodium bicarbonate injection.

Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed in flexible plastic containers is sterile through the expiration date on the label when stored under recommended conditions.

Note:

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

How supplied

Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection), 25 mg/mL, containing phenol 0.5% as preservative, is available as follows:

NDC 0173-0362-38, 2-mL single-dose vials (Tray of 10)

NDC 0173-0363-01, 6-mL multidose vials (Singles)

Store between 4° and 25°C (39° and 77°F); excursions permitted to 30°C (86°F). Protect from light.

Ranitidine (Albis) Injection (Ranitidine (Albis) hydrochloride injection) Premixed, 50 mg/50 mL, in 0.45% sodium chloride, is available as a sterile, premixed solution for IV administration in single-dose, flexible plastic containers (NDC 0173-0441-00) (case of 24). It contains no preservatives.

Store between 2° and 25°C (36° and 77°F). Protect from light.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat; however, brief exposure up to 40°C does not adversely affect the product. Protect from freezing.

GlaxoSmithKline, Research Triangle Park, NC 27709. Ranitidine (Albis)® (Ranitidine (Albis) hydrochloride injection) Injection: GlaxoSmithKline, Research Triangle Park, NC 27709. Ranitidine (Albis)® (Ranitidine (Albis) hydrochloride injection) Injection Premixed: Manufactured for GlaxoSmithKline, Research Triangle Park, NC 27709 by Hospira, Inc., Lake Forest, IL 60045. February 2009.

Ranitidine (Albis) interactions

See also:
What other drugs will affect Ranitidine (Albis)?

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Ranitidine (Albis) has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Procainamide

Ranitidine (Albis), a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of Ranitidine (Albis) (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual Ranitidine (Albis) doses, it may be prudent to monitor for procainamide toxicity when administered with oral Ranitidine (Albis) at a dose exceeding 300 mg per day.

Warfarin

There have been reports of altered prothrombin time among patients on concomitant warfarin and Ranitidine (Albis) therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with Ranitidine (Albis).

Ranitidine (Albis) may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir

Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine

Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H-receptor antagonists with delavirdine is not recommended.

Gefitinib

Gefitinib exposure was reduced by 44% with the coadministration of Ranitidine (Albis) and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.

Glipizide

In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral Ranitidine (Albis). Use appropriate clinical monitoring when initiating or discontinuing Ranitidine (Albis).

Ketoconazole

Oral ketoconazole exposure was reduced by up to 95% when oral Ranitidine (Albis) was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of Ranitidine (Albis) (150 mg twice daily) is unknown.

Midazolam

Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral Ranitidine (Albis) at a dose of 150 mg twice daily. However, in another interaction study in 8 volunteers receiving IV midazolam, a 300 mg oral dose of Ranitidine (Albis) increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when Ranitidine (Albis) is coadministered with oral midazolam.

Triazolam

Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral Ranitidine (Albis) at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.

Ranitidine (Albis) side effects

See also:
What are the possible side effects of Ranitidine (Albis)?

Transient pain at the site of IM injection has been reported. Transient local burning or itching has been reported with IV administration of Ranitidine (Albis).

The following have been reported as events in clinical trials or in the routine management of patients treated with oral or parenteral Ranitidine (Albis). The relationship to therapy with Ranitidine (Albis) has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ranitidine (Albis).

Central Nervous System

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular

As with other H-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, asystole, atrioventricular block, and premature ventricular beats.

Gastrointestinal

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic

In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days. There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, Ranitidine (Albis) should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported.

Musculoskeletal

Rare reports of arthralgias and myalgias.

Hematologic

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine

Controlled studies in animals and humans have shown no stimulation of any pituitary hormone by Ranitidine (Albis) and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Ranitidine (Albis) has been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving Ranitidine (Albis), but the incidence did not differ from that in the general population.

Integumentary

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.

Other

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

Ranitidine (Albis) contraindications

See also:
What is the most important information I should know about Ranitidine (Albis)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Do not use this medication if you are allergic to Ranitidine (Albis).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.

Using Ranitidine (Albis) may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

Ranitidine (Albis) granules and effervescent tablets must be dissolved in water before you take them.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.

Avoid drinking alcohol. It can increase the risk of damage to your stomach.

It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

What is Sucralfate (Albis)?

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

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

Sucralfate (Albis) 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, Sucralfate (Albis) 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

Sucralfate (Albis) indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Sucralfate (Albis) tablets, USP are indicated in:

Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with Sucralfate (Albis) may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

How should I use Sucralfate (Albis)?

Use Sucralfate (Albis) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Sucralfate (Albis) 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.
  • Sucralfate (Albis) should only be taken by mouth. Do NOT inject Sucralfate (Albis).
  • Do not take an antacid for at least 30 minutes before or after taking Sucralfate (Albis).
  • It may take 4 to 8 weeks for complete healing of your ulcer. Continue taking Sucralfate (Albis) for the full course of treatment even if you feel better.
  • Do not take Sucralfate (Albis) at the same time as other medicines. Take Sucralfate (Albis) at least 2 hours after other medicines. If you are not sure about the best time to take Sucralfate (Albis), ask your doctor or pharmacist.
  • If you miss a dose of Sucralfate (Albis), 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 Sucralfate (Albis).

Uses of Sucralfate (Albis) in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Sucralfate (Albis) is used to treat stomach ulcers, bowel ulcers and inflammation of the stomach.

Sucralfate (Albis) description

Each tablet contains 1g of Sucralfate (Albis).

Sucralfate (Albis) 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.

Sucralfate (Albis) is α-D-glucopyranoside, β-D-fructofuranosyl, octakis (hydrogen sulfate), aluminum complex. Its molecular formula is C12HmAl16OnS8 (m and n are approximately 54 and 75, respectively, resulting in an average molecular weight of about 2086 daltons).

Sucralfate (Albis) dosage

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 Sucralfate (Albis) in pediatric patients have not been established. However, the use of Sucralfate (Albis) 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 Sucralfate (Albis) can result in complete healing of a duodenal ulcer, a successful course of treatment with Sucralfate (Albis) should not be expected to alter the posthealing frequency or severity of duodenal ulceration.

When Sucralfate (Albis) is given orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of Sucralfate (Albis) 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 Sucralfate (Albis) 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. Sucralfate (Albis) 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. Sucralfate (Albis) 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.

Sucralfate (Albis) interactions

See also:
What other drugs will affect Sucralfate (Albis)?

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

Dolutegravir: Sucralfate (Albis) may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after Sucralfate (Albis). Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after Sucralfate (Albis). 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: Sucralfate (Albis) may decrease the serum concentration of Furosemide. Sucralfate (Albis) may impair the absorption of furosemide. Management: Avoid concomitant oral administration of furosemide and Sucralfate (Albis). Separate administration by at least 2 hours. Does not apply to parenterally administered furosemide. Consider therapy modification

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

Levothyroxine: Sucralfate (Albis) may decrease the serum concentration of Levothyroxine. Monitor therapy

Multivitamins/Fluoride (with ADE): May increase the serum concentration of Sucralfate (Albis). Specifically, the absorption of aluminum may be increased. Sucralfate (Albis) may decrease the serum concentration of Multivitamins/Fluoride (with ADE). More specifically, Sucralfate (Albis) may impair the absorption of fluoride. Management: Avoid administration of aluminum-containing products, such as Sucralfate (Albis), 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 Sucralfate (Albis). Specifically, the absorption of aluminum from Sucralfate (Albis) 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: Sucralfate (Albis) may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate administration. Administering oral phosphate supplements at least 2 hours before Sucralfate (Albis) may reduce the significance of the interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification

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

Quinolones: Sucralfate (Albis) may decrease the serum concentration of Quinolones. Management: Avoid concurrent administration of quinolones and Sucralfate (Albis) 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: Sucralfate (Albis) may decrease the serum concentration of Sulpiride. Management: Separate administration of Sucralfate (Albis) and sulpiride by at least 2 hours in order to minimize the impact of Sucralfate (Albis) on sulpiride absorption. Consider therapy modification

Tetracyclines: Sucralfate (Albis) may decrease the absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to Sucralfate (Albis) in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to Sucralfate (Albis). 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 Sucralfate (Albis). Specifically, the absorption of aluminum from Sucralfate (Albis) may be increased, leading to an increase in the serum aluminum concentration. Avoid combination

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

Sucralfate (Albis) side effects

See also:
What are the possible side effects of Sucralfate (Albis)?

Adverse reactions to Sucralfate (Albis) tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Sucralfate (Albis), 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 Sucralfate (Albis) tablets. Similar events were reported with Sucralfate (Albis). However, a causal relationship has not been established. Cases of hyperglycemia have been reported with Sucralfate (Albis).

Bezoars have been reported in patients treated with Sucralfate (Albis). 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 Sucralfate (Albis) and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate (Albis) is not intended for intravenous administration.

Sucralfate (Albis) contraindications

See also:
What is the most important information I should know about Sucralfate (Albis)?

Before taking Sucralfate (Albis), tell your doctor if you have diabetes, kidney disease, or if you are on dialysis.

Take Sucralfate (Albis) 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 Sucralfate (Albis). Sucralfate (Albis) 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 Sucralfate (Albis) to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking Sucralfate (Albis).

Active ingredient matches for Albis:

Ranitidine/sucralfate/tripotassium bismuth dicitrate in Vietnam.


Unit description / dosage (Manufacturer)Price, USD
Albis 3 Blister x 10 Tablet
Albis 6 Blister x 10 Tablet

List of Albis substitutes (brand and generic names):

References

  1. PubChem. "ranitidine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "ranitidine". http://www.drugbank.ca/drugs/DB00863 (accessed September 17, 2018).
  3. DTP/NCI. "ranitidine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Albis are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Albis. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported useful

No survey data has been collected yet


Consumer reported price estimates

No survey data has been collected yet


1 consumer reported time for results

To what extent do I have to use Albis before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Albis. To get the time effectiveness of using Albis drug by other patients, please click here.
Users%
1 day1
100.0%


3 consumers reported age

Users%
30-451
33.3%
46-601
33.3%
16-291
33.3%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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