Baby Gas And Colic Plus Stomach Cramps
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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.
Limitations of Use:
- Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
- Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB [see Microbiology (12.4)].
- The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.2)].
History
There is currently no drug history available for this drug.
Other Information
RAPIVAB (peramivir) is an inhibitor of influenza virus neuraminidase. The chemical name is (1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-(carbamimidoylamino)-2-hydroxycyclopentanecarboxylic acid, trihydrate. The chemical formula is C15H28N4O4 ∙ 3H2O, representing a molecular weight of 382.45. The molecular structure is as follows:
RAPIVAB injection is a clear, colorless, sterile, isotonic solution (200 mg per 20 mL) in glass vials fitted with rubber stoppers and royal blue flip-off seals. Each mL contains 10 mg peramivir (on an anhydrous basis) in 0.9% sodium chloride solution. The pH may have been adjusted with sodium hydroxide, USP and/or hydrochloric acid, USP. The pH is 5.5 – 8.5.
Sources
Baby Gas And Colic Plus Stomach Cramps Manufacturers
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Similasan Corporation
![Baby Gas And Colic Plus Stomach Cramps (Atropa Belladonna, Matricaria Recutita, Anamirta Cocculus Whole, Citrullus Colocynthis Fruit Pulp And Magnesium Phosphate, Dibasic Trihydrate) Tablet, Orally Disintegrating [Similasan Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Baby Gas And Colic Plus Stomach Cramps | Biocryst Pharmaceuticals, Inc.
2.1 Dosage in Acute Uncomplicated InfluenzaAdminister RAPIVAB within 2 days of onset of symptoms of influenza.
The recommended dose of RAPIVAB in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.
2.2 Dosing in Patients with Renal ImpairmentSignificantly increased drug exposures were observed when RAPIVAB was administered to subjects with renal dysfunction [see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. No dose adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher [see Clinical Pharmacology (12.3)].
In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1) [see Clinical Pharmacology (12.3)].
Table 1. Dosage Adjustment for Patients with Altered Creatinine Clearance Creatinine Clearance* (mL/min) ≥50 30-49 10-29 * Calculated using the Cockcroft and Gault equation. Recommended Dose (mg) 600 200 100 2.3 Preparation of RAPIVAB for Intravenous InfusionUse aseptic technique during the preparation of RAPIVAB to prevent inadvertent microbial contamination. There is no preservative or bacteriostatic agent present in the solution.
Follow the steps below to prepare a diluted solution of RAPIVAB:
(a) Do not use if seal over bottle opening is broken or missing. (b) Visually inspect RAPIVAB for particulate matter and discoloration prior to administration. (c) Dilute an appropriate dose of RAPIVAB 10 mg/mL solution [see Dosage and Administration (2)] in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's to a maximum volume of 100 mL. (d) Administer the diluted solution via intravenous infusion for 15 to 30 minutes. (e) Discard any unused diluted solution of RAPIVAB after 24 hours.Once a diluted solution of RAPIVAB has been prepared, administer immediately or store under refrigerated conditions (2° to 8°C or 36° to 46°F) for up to 24 hours. If refrigerated, allow the diluted solution of RAPIVAB to reach room temperature then administer immediately.
2.4 Drug CompatibilityRAPIVAB injection is compatible with 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's. Do not mix or co-infuse RAPIVAB with other intravenous medications.
RAPIVAB injection is compatible with materials commonly used for administration such as polyvinylchloride (PVC) bags and PVC-free bags, polypropylene syringes, and polyethylene tubing.
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