Acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine and Afatinib Dimaleate

• Generic Name: acetaminophen / dextromethorphan / pseudoephedrine / pyrilamine
• Dosage Forms: n.a.
• Other Brand Names: Robitussin Night Relief

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Pyrilamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine may also be used for purposes not listed in this medication guide.

• Generic Name: afatinib
• Dosage Forms: n.a.
• Other Brand Names: Gilotrif

First-line treatment of metastatic NSCLC in patients with tumors positive for nonresistant epidermal growth factor receptor (EGFR) mutations (e.g., exon 19 deletions [del19], exon 21 substitution [L858R] mutations) as detected by an FDA-approved diagnostic test (designated an orphan drug by FDA for this use). Nonresistant EGFR mutations are those where efficacy of afatinib may be predicted by a clinically meaningful reduction in tumor size at the recommended dosage of the drug and/or inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation is expected at afatinib concentrations sustainable at the recommended dosage.

Treatment of metastatic squamous NSCLC that has progressed following therapy with platinum-based chemotherapy (designated an orphan drug by FDA for this use).

Safety and efficacy not established in patients with resistant EGFR mutations.