V-Penum Side effects

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What are the possible side effects of V-Penum?

Get emergency medical help if you have any of these signs of an allergic reaction to V-Penum: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Common V-Penum side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of V-Penum in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Adult Patients: During reported clinical investigations, 2,904 immunocompetent adult patients were treated for infections outside the CNS with V-Penum (500 or 1,000 mg every 8 hrs). Deaths in 5 patients were assessed as possibly related to V-Penum; 36 patients (1.2%) had V-Penum discontinued because of adverse events. Many patients in these reported trials were severely ill and had multiple background diseases, physiological impairments, and were receiving multiple other drug therapies in the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with V-Penum.

Local Adverse Reaction: Local adverse reactions that were reported irrespective of the relationship to therapy with V-Penum were as follows: Inflammation at the injection site (2.4%), injection site reaction (0.9%), phlebitis/thrombophlebitis (0.8%), pain at the injection site (0.4%), edema at the injection site (0.2%).

Systemic Adverse Reactions: Systematic adverse clinical reactions that were reported irrespective of the relationship to V-Penum occurring in >1% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%) and pruritus (1.2%).

Additional adverse systemic clinical reactions that were reported irrespective of relationship to therapy with V-Penum and occurring in ≤1% but >0.1% of the patients are listed as follows within each body system in order of decreasing frequency: Bleeding Events were Seen as Follows: Gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%), summing to 1.2%.

Body as a Whole: Pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement chills, pelvic pain.

Cardiovascular: Heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, syncope.

Digestive System:

Oral moniliasis, anorexia, cholestatic jaundice/jaundice, ileus, hepatic failure, dyspepsia, intestinal obstruction.

Hemi/Lymphatic: Anemia, hypochromic anemia, hypervolemia.

Metabolic/Nutritional: Peripheral edema, hypoxia.

Nervous System: Insomnia, agitation/delirium, confusion, dizziness, seizure, nervousness, paresthesia, hallucinations, somnolence, anxiety depression, asthenia.

Respiratory: Respiratory disorder, dyspnea, pleural effusion, asthma, increased cough, lung edema.

Skin Appendages: Urticaria, sweating, skin ulcer.

Urogenital System: Dysuria, kidney failure, vaginal moniliasis, urinary incontinence.

Adverse Laboratory Changes: Adverse Laboratory Changes that were Reported Irrespective of Relationship to V-Penum and Occurring in >0.2% of the Patients Were as Follows: Hepatic: Increased serum glutamic-pyruvic transaminase (SGPT), alanine transaminase (ALT), serum glutamic-oxaloacetic transaminase (SGOT), aspartate transaminase (AST), alkaline phosphatase, lactate dehydrogenase (LDH), and bilirubin. Hematologic increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased whole blood count (WBC), shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia.

Urinalysis: Presence of red blood cells.

Renal: Increased creatinine and increased blood urea nitrogen (BUN).

Note: For patients with varying degrees of renal impairment, the incidence of head failure, kidney failure, seizure and shock reported irrespective of relationship to V-Penum increased in patients with moderately severe renal impairment CrC >10-26 mL/min.

Complicated Skin and Skin Structure Infection: In a reported study of complicated skin and skin structure infection, the type of clinical adverse reactions were similar to those listed as mentioned previously. The patients with the most common adverse events with an incidence of >5% were: Headache (7.8%), nausea (7.8%), constipation (7%), diarrhea (7%), anemia (5.5%) and pain (5.1 %). Adverse events with an incidence of >1%, and not listed as mentioned previously, include: Pharyngitis, accidental injury gastrointestinal disorder; hypoglycemia; peripheral vascular disorder and pneumonia.

Pediatric Patients: V-Penum was studied in 515 pediatric patients (>3 months to <13 years) with serious bacterial infections (excluding meningitis) at dosages of 10-20 mg/kg every 8 hrs. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably or definitely related to V-Penum and their rates of occurrence as follows: Diarrhea (3.5%), rash (1.6%), nausea and vomiting (0.8%).

Meropem was studied in 321 pediatric patients (>3 months to <17 years) with meningitis at a dosage of 40 mg/kg every 8 hrs. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably or definitely related to V-Penum and their rates of occurrence as follows: Diarrhea (4.7%), rash (most diaper area moniliasis) (3.1%), oral moniliasis (1.9%), glossitis (1%).

In the meningitis studies the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received V-Penum and those who received comparator agents (either cefotaxime or ceftriaxone). In the V-Penum treated group, 12/15 patients with seizures had late onset seizures (defined as occurring or later) versus 7,120 in the comparator arm.

Adverse Laboratory Changes: Laboratory abnormalities seen in the pediatric-aged patients in both the pediatric and the meningitis studies are similar to those reported in adult patients. There is no experience in pediatric patients with renal impairment.

Post-Marketing Experience: World wide post-marketing adverse events not previously listed in the product label and reported as possibly, probably or definitely drug related are listed within each body system in order of decreasing severity.

Hematology: Agranulocytosis, neutropenia and leukopenia; a positive Coombs' test and hemolytic anemia toxic epidermal necrolysis, Stevens-Johnson syndrome (SJS), angioedema and erythema multiform.

What is the most important information I should know about V-Penum?

V-Penum contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For V-Penum, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to V-Penum or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

References

  1. DailyMed. "CILASTATIN SODIUM; IMIPENEM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "MEROPENEM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. DailyMed. "CILASTATIN SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for V-Penum 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 V-Penum. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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