konvomep
Pharmaranks rates Konvomep 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Konvomep is a combination medicine containing Omeprazole and Sodium Bicarbonate.
Omeprazole and Sodium Bicarbonate · by Azurity
Available as a generic: Omeprazole and Sodium Bicarbonate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Omeprazole and Sodium Bicarbonate
- Form
- Kit
- Strength
- Omeprazole 2MG/ML; Sodium Bicarbonate 84MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Azurity
- Half-life
- about 0.5 to 1 hour (roughly half an hour to an hour) in healthy adults (how long it stays in your system)
- What the pharmacy pays
- ~$1.52 for 30 — not your price
- FDA application
- NDA213593
What is Konvomep?
From the FDA label:KONVOMEP (omeprazole and sodium bicarbonate for oral suspension) is a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17 H 19 N 3 O 3 S, with a molecular weight of 345.42. The structural formula is: Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Sodium bicarbonate raises the gastric pH and protects the omeprazole from acid degradation. Sodium bicarbonate is a white crystalline powder. It is soluble in water and insoluble in alcohol. One gram of sodium bicarbonate dissolves in 12 mL of water at 25ºC. The pH of a freshly prepared 0.1 molar aqueous solution is 8.3 at 25ºC. Aqueous solutions slowly convert to sodium carbonate through loss of carbon dioxide. The molecular formula is NaHCO 3 and the molecular weight is 84.01. The structural formula is: KONVOMEP is supplied as a kit. Each kit is comprised…
How to use
Recommended doses of KONVOMEP in the table below are based upon the omeprazole content. ( 2.2 ) Indication Recommended Adult Dosage ( 2.2 ) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days 2.1 Important Administration Instructions •KONVOMEP is a kit of two bottles: one bottle containing omeprazole powder and one bottle of diluent containing sodium bicarbonate. •KONVOMEP is for reconstitution by a healthcare provider for use in adults. •After reconstitution, each mL of KONVOMEP contains 2 mg of omeprazole and 84 mg of sodium bicarbonate. •Take the sodium content of KONVOMEP into consideration when prescribing this product [see Warnings and Precautions ( 5.3 )] . •Recommended doses throughout the labeling are based upon the omeprazole component of KONVOMEP. 2.2 Dosage Regimen The recommended dosage regimen in adults of KONVOMEP by indication is summarized in Table 1 . Recommended dosage is based upon the omeprazole content of KONVOMEP. Table 1: Recommended Dosage Regimen of KONVOMEP for Adults by Indication Indication Recommended Dosage Treatment Duration Treatment of Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially;…
Side effects
The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] . Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] . Bone Fracture [see Warnings and Precautions ( 5.5 )] . Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.6 )] . Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.7 )] . Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.9 )] . Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.10 )] . Fundic Gland Polyps [see Warnings and Precautions ( 5.14 )] . Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of KONVOMEP has been established, in part, based on oral studies of an oral delayed-release omeprazole product and another oral omeprazole and…
Warnings
Important safety information
Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Sodium Content : Take sodium content into consideration in patients on a sodium-restricted diet. Avoid in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. ( 5.3 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.4 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. ( 5.5 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.6 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue KONVOMEP and refer to specialist for evaluation. ( 5.7 ) Interaction with Clopidogrel : Avoid concomitant use of KONVOMEP. ( 5.8 ) Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.9 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. ( 5.10 ) Interaction with St. John’s Wort or Rifampin : Avoid concomitant use of KONVOMEP. ( 5.11 , 7 ) Interactions with Diagnostic Investigations for Neuroendocrine Tumors : Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop KONVOMEP at least 14 days before assessing CgA levels. ( 5.12 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of KONVOMEP. ( 5.13 , 7 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.14 ) 5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with KONVOMEP does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy. 5.2 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue KONVOMEP and evaluate patients with suspected acute TIN [see Contraindications ( 4 )] . 5.3 Sodium Content Each mL of reconstituted KONVOMEP contains 84 mg of sodium bicarbonate (equivalent to 1 mEq/mL of sodium). The total content of sodium, from active and inactive ingredients per mL of reconstituted KONVOMEP is 26.3 mg (1.14 mEq). Total sodium content per 40 mg dose (volume of 20 mL) of KONVOMEP is 526 mg (22.8 mEq). Chronic administration of bicarbonate with calcium or milk can cause milk-alkali syndrome. Chronic use of sodium bicarbonate may lead to systemic alkalosis, and increased sodium intake can produce edema and weight gain. The sodium content of KONVOMEP should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for developing congestive heart failure. Avoid KONVOMEP in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid‑base balance. 5.4 Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like KONVOMEP 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 [see Adverse Reactions ( 6.2 )] . Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. 5.5 Bone Fracture Several published observational studies 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 the established treatment guidelines [see Dosage and Administration ( 2.2 ) and Adverse Reactions ( 6.2 )] . 5.6 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [see Adverse Reactions ( 6.2 )] . Discontinue KONVOMEP at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.7 Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving KONVOMEP, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations. 5.8 Interaction with Clopidogrel Avoid concomitant use of KONVOMEP with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using KONVOMEP, consider alternative antiplatelet therapy [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )] . 5.9 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…
Who should not take Konvomep
KONVOMEP is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Proton pump inhibitors (PPIs), including KONVOMEP, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions ( 7 )] . Known hypersensitivity to any components of the formulation ( 4 ) Patients receiving rilpivirine‑containing products ( 4 , 7 )
Overdose — what happens if you take too much
If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Omeprazole Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth and other adverse reactions similar to those seen in normal clinical experience with the recommended dosage [see Adverse Reactions ( 6 )] . Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Sodium Bicarbonate Overdosage of sodium bicarbonate can cause electrolyte abnormalities (hypocalcemia, hypokalemia, hypernatremia), metabolic alkalosis and seizures. Institute supportive care and correct electrolyte abnormalities.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Table 5 and Table 6 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 5: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology ( 12.3 )] . Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology ( 12.3 )] . There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-containing products : Concomitant use with KONVOMEP is contraindicated [see Contraindications ( 4 )] . Atazanavir : Avoid concomitant use with KONVOMEP. See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with KONVOMEP. See prescribing information for nelfinavir. Saquinavir : See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals : See prescribing information for specific antiretroviral drugs. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range. Methotrexate Clinical Impact: Concomitant use of omeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions ( 5.13 )] . Intervention: A temporary withdrawal of KONVOMEP may be considered in some patients receiving high‑dose methotrexate. CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clopidogrel Clinical Impact: Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see Clinical Pharmacology ( 12.3 )] . There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel. Intervention: Avoid concomitant use with KONVOMEP. Consider use of alternative anti-platelet therapy [see Warnings and Precautions ( 5.8 )] . Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation [see Clinical Pharmacology ( 12.3 )] . Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram. Cilostazol Clinical Impact: Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol) [see Clinical Pharmacology ( 12.3 )] . Intervention: Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. Phenytoin Clinical Impact: Potential for increased exposure of phenytoin. Intervention: Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin. Diazepam Clinical Impact: Increased exposure of diazepam [see Clinical Pharmacology ( 12.3 )] . Intervention: Monitor patients for increased sedation and reduce the dose of diazepam as needed. Digoxin Clinical Impact: Potential for increased exposure of digoxin [see Clinical Pharmacology ( 12.3 )] . Intervention: Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF) : Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving KONVOMEP and MMF. Use KONVOMEP with caution in transplant patients receiving MMF [see Clinical Pharmacology ( 12.3 )] . See the prescribing information for other drugs dependent on gastric pH for absorption. Tacrolimus Clinical Impact: Potential for increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. Interactions with Investigations of Neuroendocrine Tumors Clinical Impact: Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions ( 5.12 ) and Clinical Pharmacology ( 12.2 )] . Intervention: Temporarily stop KONVOMEP treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. Interaction with Secretin Stimulation Test Clinical Impact: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma. Intervention: Temporarily stop KONVOMEP treatment at least 14 days before assessing to allow gastrin levels to return to baseline [see Clinical Pharmacology ( 12.2 )] . False Positive Urine Tests for THC Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs. Intervention: An alternative confirmatory method should be considered to verify positive results. Other Clinical Impact: There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram). Intervention: Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with KONVOMEP. Table 6: Clinically Relevant Interactions Affecting Omeprazole when Co-Administered with Other Drugs CYP2C19 or CYP3A4 Inducers Clinical Impact: Decreased exposure of omeprazole when used concomitantly with strong inducers [see Clinical Pharmacology ( 12.3 )] . Intervention: St. John’s Wort, rifampin : Avoid concomitant use with KONVOMEP [see Warnings and Precautions ( 5.11 )] . Ritonavir-containing products : see prescribing information for specific drugs. CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of omeprazole [see Clinical Pharmacology ( 12.3 )] . Intervention: Voriconazole : Dosage adjustment of KONVOMEP is not usually required. See full prescribing information for voriconazole. See Full Prescribing Information for a list of clinically important drug interactions. ( 7 )
How long does Omeprazole and Sodium Bicarbonate stay in your body?
The elimination half-life of omeprazole and sodium bicarbonate is about 0.5 to 1 hour (roughly half an hour to an hour) in healthy adults — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The half-life is longer in older adults (about 1 hour) and in people with chronic liver disease (nearly 3 hours); its metabolites have little or no activity, but because omeprazole irreversibly binds the stomach's acid pump, its acid-blocking effect lasts far longer than this short half-life would suggest.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: OMEPRAZOLE capsule, delayed release — DailyMed (FDA label), Clinical Pharmacology / Pharmacokinetics.
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Konvomep rated?
- pharmaranks gives Konvomep a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Konvomep cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.52 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Konvomep?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Konvomep. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Konvomep?
- Konvomep is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Konvomep a brand-name or generic drug?
- Konvomep is a brand-name product with the active ingredient Omeprazole and Sodium Bicarbonate. Lower-cost generic equivalents containing Omeprazole and Sodium Bicarbonate are available — ask your pharmacist.
- Is Konvomep available over the counter?
- No. Konvomep is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Konvomep come in?
- Konvomep is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Konvomep FDA-registered?
- Konvomep is on record with the U.S. FDA under application number NDA213593. You can verify this on its official FDA label.
- Has Konvomep been recalled by the FDA?
- Konvomep has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Konvomep safe?
- There's no single safe-or-not verdict. pharmaranks gives Konvomep a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Konvomep?
- Konvomep's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] . Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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konvomep
70/100