Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in another section of the labeling: • Vomiting and Diarrhea [see Warnings and Precautions ( 5.1 )].
• Hepatotoxicity [see Warnings and Precautions ( 5.3 )].
• Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )].
• Prophylaxis: Common adverse reactions (≥4%) in adults were diarrhea, dreams, oral ulcers, and headache;
these events occurred in a similar or lower proportion of subjects receiving atovaquone and proguanil hydrochloride than an active comparator.
Common adverse reactions (≥5%) in pediatric patients included abdominal pain, headache, cough, and vomiting.
( 6.1 ) • Treatment: Common adverse reactions (≥5%) in adolescents and adults were abdominal pain, nausea, vomiting, headache, diarrhea, asthenia, anorexia, and dizziness.
Common adverse reactions (≥6%) in pediatric patients included vomiting, pruritus, and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5 WARNINGS AND PRECAUTIONS • Atovaquone absorption may be reduced in patients with diarrhea or vomiting.
If used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered.
In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required.
( 5.1 ) • In mixed P.
falciparum and Plasmodium vivax infection, P.
Like all medications, Atovaquone And Proguanil Hydrochloride Pediatric can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: