Consists of Aceclofenac, Rabeprazole
Overdose of Aceclofenac (Altraday) in details
Symptoms: SR tab: Headache, nausea, vomiting, epigastric pain, GI irritation and bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.
Gel: The low systemic absorption of topical aceclofenac renders overdosage extremely unlikely. In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with NSAID should be used.
Treatment: Patients should be treated symptomatically as required. Within 1-hr of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within 1-hr of ingestion of a potentially life-threatening overdosage. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least 4 hrs after ingestion of potentially toxic amounts. In case of frequent or prolonged convulsions, patients should be treated with diazepam IV. Other measures may be indicated by the patient's clinical condition. Specific therapies eg, dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein-binding and extensive metabolism. Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.
Aceclofenac (Altraday) warnings
History of GI ulceration; impaired cardiac, renal or hepatic function; hypertension; lactation. IV admin in patients with moderate or severe renal impairment; hypovolaemia or dehydration; asthma, porphyria. Monitor LFTs in patients on prolonged therapy. May prolong bleeding time; caution when used in patients with coagulation disorders or on anticoagulants. Prolonged therapy may increase risk of anaemia. 1st and 2nd trimester of pregnancy. Elderly, debilitated patients.
pregnancy:
Category B(Parenteral): Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Category C(Ophth /
Topical): Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Aceclofenac (Altraday) precautions
Aceclofenac (Altraday) should be used cautiously in patients with gastrointestinal disorders, with a history of gastrointestinal ulceration, severe impairment of hepatic function, renal or cardiac impairment, patients in recovery after major surgery, the elderly.
Effects on the Ability to Drive or Operate Machinery: Patients suffering from dizziness, vertigo or other central nervous system disorders while taking NSAIDs should refrain from driving or handling dangerous machinery.
Use in pregnancy & lactation: There is no information on the use of aceclofenac during pregnancy and on the secretion of aceclofenac to breast milk.
The use of aceclofenac should therefore be avoided in pregnancy and lactation unless, the potential benefits to the other outweigh the possible risks to the fetus.
Use in children: There are no clinical data on the use of Aceclofenac (Altraday) in children and therefore, it is not recommended for use in children.
What happens if I overdose Rabeprazole (Altraday)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.
Proper storage of Rabeprazole (Altraday):
Store Rabeprazole (Altraday) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rabeprazole (Altraday) out of the reach of children and away from pets.
Overdose of Rabeprazole (Altraday) in details
There has no been experience with large overdoses with rabeprazole. Seven (7) reports of accidental overdoses with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein-bound and is not really dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Single oral dose of rabeprazole at 786 mg/kg and 1024 mg/kg were lethal to mice and rats, respectively. The single oral dose of 2000 mg/kg was not lethal to dogs. The major symptoms of acute toxicity were hypoactivity, labored respiration, lateral or prone position and convulsion in mice and rats and watery diarrhea, tremor, convulsion and coma in dogs.
What should I avoid while taking Rabeprazole (Altraday)?
This medication can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking rabeprazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Rabeprazole (Altraday) warnings
Presence of Gastric Malignancy
Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric malignancy.
Adult patients with healed GERD were treated for up to 40 months with rabeprazole sodium delayed-release tablets and monitored with serial gastric biopsies. Adult patients without H. pylori infection (221 of 326 patients) had no clinically important pathologic changes in the gastric mucosa. Adult patients with H. pylori infection at baseline (105 of 326 patients) had mild or moderate inflammation in the gastric body or mild inflammation in the gastric antrum. Adult patients with mild grades of infection or inflammation in the gastric body tended to change to moderate, whereas those graded moderate at baseline tended to remain stable. Adult patients with mild grades of infection or inflammation in the gastric antrum tended to remain stable. At baseline 8% of patients had atrophy of glands in the gastric body and 15% had atrophy in the gastric antrum. At endpoint, 15% of patients had atrophy of glands in the gastric body and 11% had atrophy in the gastric antrum. Approximately 4% of patients had intestinal metaplasia at some point during follow-up, but no consistent changes were seen.
Interaction with Warfarin
Steady state interactions of rabeprazole and warfarin have not been adequately evaluated in patients. There have been reports of increased INR and prothrombin time in patients receiving a proton pump inhibitor and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with Rabeprazole (Altraday) Sprinkle and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including rabeprazole sodium. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Rabeprazole (Altraday) Sprinkle if acute interstitial nephritis develops.
Cyanocobalamin (vitamin B-12) Deficiency
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Rabeprazole (Altraday) Sprinkle.
Clostridium difficile Associated Diarrhea
Published observational studies suggest that PPI therapy like Rabeprazole (Altraday) Sprinkle may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents.
Bone Fracture
Several published observational studies in adults suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
Rabeprazole (Altraday) Sprinkle is indicated for short-term treatment of up to 12 weeks. Treatment for longer than 12 weeks is not recommended.
Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in adult patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Rabeprazole (Altraday) Sprinkle is indicated for short-term treatment of up to 12 weeks. Treatment for longer than 12 weeks is not recommended.
Interaction with Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
What should I discuss with my healthcare provider before taking Rabeprazole (Altraday)?
Some medical conditions may interact with Rabeprazole (Altraday). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have low blood magnesium levels, low blood vitamin B12 levels or vitamin B12 deficiency, liver problems, or stomach or bowel cancer
- if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)
Some MEDICINES MAY INTERACT with Rabeprazole (Altraday). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased
- Anticoagulants (eg, warfarin), cyclosporine, diazepam, digoxin, methotrexate, phenytoin, saquinavir, or theophylline because the risk of their side effects may be increased by Rabeprazole (Altraday)
- Atazanavir, bosutinib, dasatinib, erlotinib, indinavir, itraconazole, ketoconazole, mycophenolate, nelfinavir, nilotinib, posaconazole, or rilpivirine because their effectiveness may be decreased by Rabeprazole (Altraday)
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rabeprazole (Altraday) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Rabeprazole (Altraday) precautions
Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or esophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole (Altraday).
Patients on long-term treatment (particularly those treated for >1 year) should be kept under regular surveillance.
Patients should be cautioned that Rabeprazole (Altraday) tablets should not be chewed or crushed, but should be swallowed whole.
No evidence of significant drug-related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex-matched controls. However, because there are no clinical data on the use of Rabeprazole (Altraday) in the treatment of patients with severe hepatic dysfunction, the prescriber is advised to exercise caution when treatment with Rabeprazole (Altraday) is first initiated in such patients.
Effects on the Ability to Drive or Operate Machinery: Based on the pharmacodynamic properties and the adverse events profile, it is unlikely that Rabeprazole (Altraday) would cause an impairment of driving performance or compromise the ability to use machinery. If however, alertness is impaired due to somnolence, it is recommended that driving and operating complex machinery be avoided.
Use in pregnancy & lactation: There are no data on the safety of rabeprazole in human pregnancy.
Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to rabeprazole sodium, although low feto-placental transfer occurs in rats.
It is not known whether rabeprazole sodium is excreted in human breast milk. No studies in lactating women have been performed. Rabeprazole sodium is however excreted in rat mammary secretions. Therefore, Rabeprazole (Altraday) should not be used during breastfeeding.
Use in children: Rabeprazole (Altraday) is not recommended for use in children, as there is no experience of its use in this group.
What happens if I miss a dose of Rabeprazole (Altraday)?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DrugBank. "Aceclofenac". http://www.drugbank.ca/drugs/DB06736 (accessed September 17, 2018).
- DrugBank. "rabeprazole". http://www.drugbank.ca/drugs/DB01129 (accessed September 17, 2018).
- MeSH. "Proton Pump Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
