Carafate 1 mg: Carafate Dosage Guide – Drugs.com
Generic Carafate Availability – Drugs.com
Save
Last updated on Jun 7, 2023.
Carafate is a brand name of sucralfate, approved by the FDA in the following formulation(s):
CARAFATE (sucralfate – suspension;oral)
- Manufacturer: ABBVIE
Approval date: December 16, 1993
Strength(s): 1GM/10ML [RLD][AB]
CARAFATE (sucralfate – tablet;oral)
- Manufacturer: ABBVIE
Approved Prior to Jan 1, 1982
Strength(s): 1GM [RLD][AB]
Has a generic version of Carafate been approved?
Yes. The following products are equivalent to Carafate:
sucralfate suspension;oral
- Manufacturer: AMNEAL
Approval date: December 2, 2019
Strength(s): 1GM/10ML [AB] - Manufacturer: MYLAN
Approval date: September 12, 2022
Strength(s): 1GM/10ML [AB] - Manufacturer: VISTAPHARM
Approval date: March 15, 2022
Strength(s): 1GM/10ML [AB]
sucralfate tablet;oral
- Manufacturer: AMNEAL PHARMS
Approval date: April 15, 2022
Strength(s): 1GM [AB] - Manufacturer: NOSTRUM LABS INC
Approval date: June 8, 1998
Strength(s): 1GM [AB] - Manufacturer: TEVA
Approval date: March 29, 1996
Strength(s): 1GM [AB] - Manufacturer: ZYDUS LIFESCIENCES
Approval date: May 3, 2023
Strength(s): 1GM [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Carafate.
These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
More about Carafate (sucralfate)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (68)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- Support group
- Drug class: miscellaneous GI agents
- Breastfeeding
- En español
Patient resources
- Drug Information
- Carafate (Sucralfate Oral Suspension)
- Carafate (Sucralfate Tablets)
Professional resources
- Prescribing Information
Related treatment guides
- GERD
- Duodenal Ulcer
- Hyperphosphatemia of Renal Failure
- Duodenal Ulcer Prophylaxis
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U. S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
| AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Carafate: Package Insert – Drugs.com
Package insert / product label
Generic name: sucralfate
Dosage form: oral suspension
Drug class: Miscellaneous GI agents
Medically reviewed by Drugs.com. Last updated on Jan 1, 2023.
On This Page
- Description
- Clinical Pharmacology
- Clinical Studies
- Indications and Usage
- Contraindications
- Warnings
- Precautions
- Drug Interactions
- Adverse Reactions/Side Effects
- Overdosage
- Dosage and Administration
- How Supplied/Storage and Handling
Carafate Description
Carafate Oral Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
Carafate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. Carafate Oral Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methylcellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone emulsion USP, and sorbitol solution USP. Therapeutic category: antiulcer.
Carafate – Clinical Pharmacology
Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:
- Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
- In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
- In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.
In vitro, sucralfate adsorbs bile salts.
These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer- adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of sucralfate.
Clinical Trials
In a multicenter, double-blind, placebo-controlled study of Carafate Oral Suspension, a dosage regimen of 1 gram (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.
| Results From Clinical Trials Healing Rates for Acute Duodenal Ulcer | ||||
| Treatment | n | Week 2 Healing Rates | Week 4 Healing Rates | Week 8 Healing Rates |
| Carafate Oral Suspension | 145 | 23(16%)* | 66(46%)† | 95(66%)‡ |
| Placebo | 147 | 10(7%) | 39(27%) | 58(39%) |
*P=0.
016 †P=0.001 ‡P=0.0001
Equivalence of sucralfate oral suspension to sucralfate tablets has not been demonstrated.
Indications and Usage for Carafate
Carafate (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Contraindications
Carafate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Warnings
Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Carafate Oral Suspension. Administer Carafate Oral Suspension only by the oral route. Do not administer intravenously.
Precautions
The physician should read the “PRECAUTIONS” section when considering the use of Carafate Oral Suspension in pregnant or pediatric patients, or patients of childbearing potential.
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration.
Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with Carafate Oral Suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of Carafate Oral Suspension might be necessary.
Special Populations: Chronic Renal Failure and Dialysis Patients
When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate 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 and aluminum- containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins.
Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
Drug Interactions
Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract.
In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to Carafate Oral Suspension’s potential to alter the absorption of some drugs, Carafate Oral Suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).
There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
Pregnancy
Teratogenic effects
Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of Carafate Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient 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 (See DOSAGE AND ADMINISTRATION).
This drug 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 (See PRECAUTIONS Special Populations: Chronic Renal Failure and Dialysis Patients). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
ADVERSE REACTIONS
Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, 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
Post-marketing cases of hypersensitivity have been reported with the use of sucralfate oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.
Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.
Cases of hyperglycemia have been reported with sucralfate.
Bezoars have been reported in patients treated with sucralfate. 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.
Overdosage
Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
DOSAGE AND ADMINISTRATION
Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Carafate Oral Suspension should be administered on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Carafate Oral Suspension.
While healing with sucralfate 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.
Elderly: In general, dose selection for an elderly patient 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 (See PRECAUTIONS, Geriatric Use).
Call your doctor for medical advice about side effects. You may report side effects to Allergan USA, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.
fda.gov/medwatch.
HOW SUPPLIED
Carafate (sucralfate) Oral Suspension 1 g/10 mL is a pink suspension supplied in bottles of 420 mL (NDC 58914-170-14).
SHAKE WELL BEFORE USING. AVOID FREEZING.
Store at controlled room temperature 20-25°C (68-77°F) [see USP].
Rx Only
Prescribing Information rev. Jan 2023
Distributed by:
Allergan USA, Inc.
Madison, NJ 07940
Carafate® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.
® 2023 Allergan. All rights reserved.
Allergan® and its design are trademarks of Allergan, Inc.
v2.0USPI0170
PRINCIPAL DISPLAY PANEL
NDC 58914-170-14
Carafate
(sucralfate)
Oral
Suspension
1g/ 10mL
| Carafate sucralfate suspension | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
40
7 mL in 1 CUP, UNIT-DOSE| Labeler – Allergan, Inc. (144796497) |
Allergan, Inc.
Frequently asked questions
- Can you buy something like carafate over the counter without a prescription?
More about Carafate (sucralfate)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (68)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- Generic availability
- Support group
- Drug class: miscellaneous GI agents
- Breastfeeding
- En español
Patient resources
- Drug Information
- Carafate (Sucralfate Oral Suspension)
- Carafate (Sucralfate Tablets)
Professional resources
- Prescribing Information
- Sucralfate (AHFS Monograph)
Related treatment guides
- GERD
- Duodenal Ulcer
- Hyperphosphatemia of Renal Failure
- Duodenal Ulcer Prophylaxis
Medical Disclaimer
💊 LEVOFORD solution for infusions 100 ml 5mg/ml N1 Before use, read the instructions for use or seek advice from specialists.
Dosage form of release: solution for infusion. Primary packaging: 100 ml plastic bottle. Secondary packaging: A vial enclosed with instructions for medical use in a cardboard box.
COMPOUND:
100 ml solution contains:
Active substance: levofloxacin hemihydrate equivalent to levofloxacin – 500 mg;
Excipients: anhydrous glucose – 5% water for injection – q.s.
Solution for infusion 5 mg/ml 100 ml N1 (vials)
Antibacterial synthetic agent
1
Levofloxacin solution for infusion is used by slow intravenous infusion once or twice a day. The dose depends on the type and severity of the infection and the sensitivity of the pathogen – the causative agent of the disease.
The course of therapy with levofloxacin after the initial course of intravenous infusions, treatment can be continued with oral forms of the drug. Since oral absorption of levofloxacin is rapid and complete, the daily dose is the same for oral and intravenous administration.
Adults:
Acute sinusitis: 500 mg once a day for 10-14 days.
Complication of chronic bronchitis: 500 mg once a day for 7 days (uncomplicated), 750 mg once a day for 5 days (complicated).
Nosocomial (nosocomial) pneumonia: 500 mg once a day for 7-14 days.
Uncomplicated urinary tract infections: 250 mg once a day for 3 days.
Complicated urinary tract infections and acute pyelonephritis: 250 mg once a day for 7-10 days.
Uncomplicated skin and soft tissue infections: 500 mg once a day for 7-10 days.
Complicated skin and soft tissue infections: 750 mg once a day for 7-14 days.
Enteric fever: 500 mg once a day for 7-14 days.
Diarrhea, cholera, bacillary dysentery and enteritis: – mild to moderate forms: 500 mg (single dose).
– moderate to severe forms: 500 mg once a day for 3 days.
Children: Levofloxacin, solution for infusion, should only be used when the benefit outweighs the risk.
Safety in pediatric practice with a duration of therapy of more than 14 days has not been studied. – children aged 6 months to 5 years: 10 mg/kg every 12 hours. – children over 5 years of age: 10 mg/kg every 24 hours.
Patients with impaired renal function: Dosage adjustment is required depending on the amount of creatinine clearance.
Ions of iron, calcium, zinc, or magnesium can combine with levofloxacin and other fluoroquinolone antibiotics and prevent their absorption from the intestine into the blood. Therefore, drugs (eg, antacids) that contain iron, calcium, zinc, or magnesium should be taken at least 2 hours before or 2 hours after taking levofloxacin. Other drugs that contain these minerals and may interact similarly with levofloxacin include sucralfate (Carafate) and didanosine (Videx, Videx EC).
Taking non-steroidal anti-inflammatory drugs (NSAIDs) concomitantly with levofloxacin may increase the risk of CNS stimulation, which can lead to overexcitation.
There have also been reports of changes in blood sugar levels (rise and fall) in patients treated with fluoroquinolone antibiotics and antidiabetic drugs.
Taking fluoroquinolone antibiotics can increase blood levels of theophylline (Teodur), cyclosporine (Sandimmun, Neoral), and alter the effects of warfarin (Coumadin).
Levoford is contraindicated in patients with known hypersensitivity to levofloxacin or other quinolone antibiotics.
Levofloxacin solution for infusion should not be used:
– in patients with epilepsy;
– in patients with a history of tendon problems caused by taking fluoroquinolone antibiotics;
– in children or adolescents;
– during pregnancy;
– in women during breastfeeding.
Store in a place protected from light, at a temperature not exceeding 25°C.
Keep away from children.
BEST BEFORE DATE:
2 years from date of manufacture. Do not use after the expiration date.
From the digestive system:
– nausea, vomiting, diarrhea (including with blood), digestive disorders, loss of appetite, abdominal pain, pseudomembranous colitis; increased activity of “liver” transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.
From the side of the cardiovascular system:
– lowering blood pressure, vascular collapse, tachycardia, prolongation of the QT interval, atrial fibrillation.
From the side of metabolism:
– hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia (dry mouth, thirst, increased urination, fatigue, blurred vision, dry or itchy skin, arrhythmia).
From the nervous system:
– headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, convulsions.
From the sense organs:
– impaired vision, hearing, smell, taste and tactile sensitivity.
From the musculoskeletal system:
– arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.
From the urinary system:
– hypercreatinemia, interstitial nephritis, acute renal failure.
From the side of the hematopoietic organs:
– eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.
Allergic reactions:
– itching and hyperemia of the skin; swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, dyspnea, anaphylactic shock, allergic pneumonitis, vasculitis.
Others:
– photosensitivity, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.
Following a 60-minute intravenous infusion of 500 mg levofloxacin to healthy volunteers, the mean peak plasma concentration was 6.
2 µg/mL. Pharmacokinetic characteristics after a single dose of 500 mg of levofloxacin IV, respectively, are: Cmax 6.2 ± 1.0 μg / ml, Tmax – 1.0 ± 0.1 hours, half-life 6.4 ± 0.7 hours. Pharmacokinetics levofloxacin is linear and predictable with single and multiple doses. The plasma profile of levofloxacin concentrations after intravenous administration is similar to that of oral administration, therefore, oral and intravenous routes of administration can be considered interchangeable. The mean volume of distribution of levofloxacin ranges from 89up to 112 liters after a single and multiple dose of 500 mg IV. Communication with plasma proteins is 30-40%. The mean terminal half-life of levofloxacin is 6 to 8 hours after a single or multiple dose. Levofloxacin penetrates well into organs and tissues: lungs, bronchial mucosa and sputum, organs of the genitourinary system, incl. prostate gland, bone tissue, cerebrospinal fluid, polymorphonuclear leukocytes, alveolar macrophages. Levofloxacin is predominantly excreted in the urine unchanged.
In the liver, a small part is oxidized and/or deacetylated. After oral administration, approximately 87% of the dose taken is excreted in the urine unchanged within 48 hours. Less than 4% found in feces over a 72 hour period
Levoford is indicated for the treatment of the following mild, moderate and severe infections caused by susceptible strains of pathogenic microorganisms, namely:
– Acute maxillary sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis;
– Complication of chronic bronchitis caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis;
– Nosocomial (nosocomial) pneumonia caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae;
– Uncomplicated and complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus;
– Acute pyelonephritis caused by Escherichia coli;
– Uncomplicated and complicated infections of the skin and soft tissues, including abscesses, cellulitis, boils, impetigo, pyoderma, wound infections caused by Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis;
– Intestinal infections caused by Enterobacter sp.
, Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.
In case of acute overdose, gastric lavage should be carried out. The patient should be monitored and receive adequate fluids. Levofloxacin cannot be effectively eliminated by hemodialysis or peritoneal dialysis.
This drug is prescribed with caution to children. Contact your healthcare provider for details.
Drug analogues
AMIZOLIDE tablets 200mg N9
NEVIVIR tablets 200mg N59
Benzylpenicillin powder 1000000u N9
90 002 Cefazolin BELMED powder 500mg N4
CEBANEX powder 2g N0
GLEVO 500 tablets 500mg N24
PROBACTAM powder 1, 5g N4
AMPIOX RNP capsules 250mg N99
MR LEVAMAX solution for infusion 100 ml 5mg/ml
AUGMENTIN tablets 875mg/125mg N13
STREPTO MICIN powder 1g N0
CLAVONIR powder 500mg+100mg N0
AMPIOX LP powder 0.
5g N49
LEVATIN solution 200ml 1000mg/200ml
TETRACYCLINE ointment 10g 1%
DISPARI powder 3g N0
CEFAZOLIN powder 1.0g from Biosynthesis
LOFEL solution for injection 100 ml 500 mg/100 ml
LEVOLET solution for infusion 100 ml 500 mg/100 ml
LEFLOX 250 mg N2
AMIZOLIDE tablets 200 mg N9 90 003
NEVIVIR tablets 200mg N59
Benzylpenicillin powder 1000000 units N9
Cefazolin BELMED powder 500mg N4
CEBANEX powder 2g N0
GLEVO 500 tablets 500mg N24
PROBACTAM powder 1.5g N4
AMPI OKS RNP capsules 250mg N99
MR LEVAMAX solution for infusions 100 ml 5 mg/ml
AUGMENTIN tablets 875mg/125mg N13
STREPTOMYCIN powder 1g N0
KLAVONIR powder 500mg+100mg N0
AMPIOX LP powder 0.5g N49
LEVATIN solution 20 0 ml 1000mg/200 ml
TETRACYCLINE ointment 10g 1%
DISPARI powder 3g N0
CEFAZOLIN powder 1.0g from Biosintez
LOFEL solution for injection 100 ml 500mg/100ml
LEVOLET solution for infusion 100ml 500mg/100 ml
LEFLOX 250mg N2
AMIZOLIDE tablets 200mg N9
New medicines
LEVOFLOXACIN capsules 250mg N10 from Belmedpreparata RUE
GLEVO 500 tablets 500mg N24
LOFEL solution for injection 100ml 500mg/100ml
LEVOLET solution for infusion 100 ml 500 mg/100 ml
Lotix
LEVOFLOXACIN 0.
25 tablets N10 from LLC Ozon
SPIROFLOX OPHTHALMO eye drops 5 ml 0.5%
FLEXID 0.005/ml solution for infusion 100 ml N0 9 0003
LEVOMAK solution for infusions 100 ml 500 mg/ 100 ml
LOTIX tablets 250 mg N6
LEVOSEF 500 solution for infusion 100 ml 5 mg/5 ml 03
AVATAK tablets 250mg N4
AVIFLOKS tablets 500mg N4
LEVOFLOXACIN 0.25 tablets N10 from Biokhimik JSC
LEVODEKS 250 tablets 250mg N5
LEVOFLOXACIN 0.25 tablets N10 from Vertex Joint Stock Company
LEFTRIN tablets 500mg N6 from Torrent Pharmaceuticals Ltd
LEVOFLOXACIN eye drops 5 ml 0.5 %
LEVOFLOXACIN capsules 250mg N10 from Belmedpreparata RUP
GLEVO 500 tablets 500mg N24
LOFEL injection solution 100 ml 500mg/100 ml
L EVOLET solution for infusions 100 ml 500 mg/100 ml
Lotix
LEVOFLOXACIN 0.25 tablets N10 from LLC Ozon
SPIROFLOX OPHTHALMO eye drops 5 ml 0.5%
FLEXID 0.005/ml solution for infusion 100 ml N0 9 0003
LEVOMAK solution for infusions 100 ml 500 mg/ 100 ml
LOTIX tablets 250 mg N6
LEVOSEF 500 solution for infusion 100 ml 5 mg/5 ml 03
AVATAK tablets 250mg N4
AVIFLOKS tablets 500mg N4
LEVOFLOXACIN 0.
25 tablets N10 from Biokhimik JSC
LEVODEKS 250 tablets 250mg N5
LEVOFLOXACIN 0.25 tablets N10 from Vertex Joint Stock Company
LEFTRIN tablets 500mg N6 from Torrent Pharmaceuticals Ltd
LEVOFLOXACIN eye drops 5 ml 0.5 Peptazol 15mg0232
What are the possible side effects of peptazole 15 mg?
Clinical
Worldwide, more than 10,000 patients have been treated with peptazole 15 mg in phase 2 or phase 3 clinical trials involving various doses and durations of treatment. Overall, treatment with Peptazole 15 mg was well tolerated in both short and long term studies.
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in clinical trials of a medicinal product cannot be directly compared with the frequency in clinical trials of another medicinal product and may not reflect rates observed in clinical practice.
The following adverse reactions were reported by the attending physician to have a possible or probable relationship with the drug in 1% or more of patients receiving Peptazole 15 mg, and occurred with a greater frequency in patients receiving Peptazole 15 mg than in patients receiving placebo in table.
1.
Headache was also observed at an incidence greater than 1% but was more common with placebo. The incidence of diarrhea was similar in patients treated with placebo and in patients treated with 15 mg and 30 mg peptazole 15 mg, but higher in patients treated with 60 mg peptazole 15 mg (2.9%, 1.4%, 4.2% and 7.4% respectively).
The most common treatment-related adverse event during maintenance therapy was diarrhea.
In a risk reduction study of peptazole 15 mg for NSAID-associated gastric ulcers, the incidence of diarrhea in patients treated with peptazole 15 mg, misoprostol, and placebo was 5%, 22%, and 3%, respectively.
Another study for the same indication, where patients received either a COX-2 inhibitor or peptazole 15 mg and naproxen, demonstrated that the safety profile was similar to the previous study. Additional reactions from this study, not previously observed in other clinical trials with Peptazole 15 mg, included contusion, duodenitis, epigastric discomfort, esophageal upset, fatigue, hunger, oral hernia, hoarseness, impaired gastric emptying, metaplasia, and renal failure.
Additional side effects occurring in less than 1% of patients or subjects treated with peptazole 15 mg in home trials are shown below: in the chest (not otherwise specified), chills, swelling, fever, influenza syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck stiffness, pain, pelvic pain
Cardiovascular system – angina, arrhythmia, bradycardia, cerebrovascular accident / cerebral infarction, hypertension / hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation
Digestive system – abnormal stool, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, belching, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundicoid polyps, gastritis , gastroenteritis, gastrointestinal anomaly, gastrointestinal disorders, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea, vomiting and diarrhea, gastrointestinal moniliasis , rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis
Endocrine system – diabetes mellitus, goiter, hypothyroidism
Hemic and lymphatic system – anemia, hemolysis, lymphadenopathy
Metabolic and nutritional disorders – beriberi, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss 9000 3
Musculoskeletal system – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia gravis, ptosis, synovitis
Nervous system – abnormal dreams, agitation, amnesia, restlessness, apathy, confusion, convulsions , dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, exacerbation of hostility, hyperkinesia, hypertension, hypoesthesia, insomnia, decrease / increase in libido, nervousness, paresthesia, sleep disturbance, drowsiness, drowsiness
Respiratory system – asthma, bronchitis, increased cough, dyspnea, epistaxis, hemoptysis, laryngeal neoplasms, pulmonary fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorders, upper respiratory tract inflammation/infection, rhinitis, sinusitis, stridor
Skin and adnexa – acne, alopecia, contact dermatitis, dry skin, fixed rash, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin cancer, skin disease, sweating, urticaria
Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eye, ear/eye disorder, eye pain, glaucoma, otitis media, paromia, photophobia, retinal degeneration/disorder, loss of taste, taste perversion, tinnitus, visual field defect
Urogenital system – abnormal menstruation, breast enlargement, chest pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, renal calculus, kidney pain, leukorrhea, menorrhagia, menstrual disturbance cycle, penile disorder, polyuria, testicular disorder, urinary pain, urinary tract retention, urinary urgency, vaginitis.
Post-marketing experience
Additional side effects have been reported since Peptazole 15 mg delayed-release capsules and Peptazole 15 mg delayed-release tablets were marketed. Most of these cases are related to a foreign source, and the association with peptazole 15 mg delayed-release capsules and peptazole 15 mg delayed-release tablets has not been established. Because these reactions have been reported voluntarily from a population of unknown size, frequency estimates cannot be made. These events are listed below by the COSTART body system.
Body as a whole – anaphylactic/anaphylactoid reactions; Digestive system – hepatotoxicity, pancreatitis, vomiting; Hemic and lymphatic system – agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Musculoskeletal system – bone fracture, myositis; Skin and appendages – severe dermatological reactions including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis (some fatal) Special Senses – impaired speech; Urogenital system – interstitial nephritis, urinary retention.
Combination therapy with amoxicillin and clarithromycin
In clinical trials using combination therapy with peptazole 15 mg plus amoxicillin and clarithromycin and peptazole 15 mg plus amoxicillin, no adverse reactions associated with these drug combinations were observed. Adverse reactions that have occurred have been limited to those previously reported with Peptazole 15 mg, amoxicillin or clarithromycin.
Triple therapy: peptazole 15 mg / amoxicillin / clarithromycin
The most common adverse reactions in patients treated with triple therapy for 14 days were diarrhea (7%), headache (6%) and taste perversion (5%). There were no statistically significant differences in reported adverse reactions between 10- and 14-day triple therapy regimens. No treatment-related adverse reactions were observed with significantly higher rates of triple therapy than with any dual therapy regimen.
Dual therapy: peptazole 15 mg / amoxicillin
The most common adverse reactions in patients treated with peptazole 15 mg three times a day plus amoxicillin three times a day in dual therapy were diarrhea (8%) and headache (7%).
No treatment-related adverse reactions were observed at significantly higher rates with Peptazole 15 mg three times a day plus amoxicillin three times a day dual therapy than with Peptazole 15 mg alone.
For information on adverse reactions with amoxicillin or clarithromycin, see Full Prescribing Information sections.
Laboratory values
The following changes in laboratory parameters in patients treated with Peptazol 15 mg have been reported as adverse reactions:
Liver dysfunction, increased SGOT (AST) increased SGPT (ALT) increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/lowered cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, elevated gastrin, and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria and hematuria have also been reported.