Generic Xyzal (Levocetirizine 5 mg Tablets) – Product Information
Generic Xyzal (Cetcip L tablets) is used for the relief of symptoms associated with seasonal and perennial allergic rhinitis. Levocetirizine tablets are also used for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria. Cetcip L tablets are manufactured by cipla Ltd. in the strengths of 5 mg.
Levocetirizine HCl is the 3rd generation non-sedative antihistamine following the popular brands Zyrtec® & Reactine®. It is used to treat symptoms of year-round perennial allergies (sneezing, stuffy nose, runny nose and itching of the nose) in adults and children who are at least 6 months old as well as seasonal allergies in adults and children who are at least 2 years old. It is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
The block buster drug Cetirizine sold under the brand names of Zyrtec® & Reactine® reached an all time high sales in 2008 but has since dropped as the 3rd generation composition Levocetirizine is becoming globally known. Levocetirizine is found to be more effective and with less side effects making it the future block buster antihistamine.
It is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.
Levocetirizine Tablets (Generic Xyzal) – Dosage
The dosage of Levocetirizine Tablets (Generic Xyzal) is given below:
Adults and children 12 years of age and older:
One 5 mg tablet once daily in the evening
Children 6 to 11 years of age:
2.5 mg once daily in the evening
Children 6 months to 5 years of age:
1.25 mg (1/2 teaspoon oral solution) [2.5ml] once daily in the evening
Adjust the dose in patients 12 years of age and older with decreased renal function
How to Use Generic Xyzal (Cetcip L by cipla)
Take Oriel tablets as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
It is very important not to give a child more than the prescribed dose of this medication. A child’s body absorbs twice as much of the same dose size as an adult’s body.
You may take this medication with or without food, usually once per day, in the evening.
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
Levocetirizine Side effects
The most common side effects of Levocetirizine tablets (Generic Xyzal) with an occurrence rate of 2% or more and greater than placebo were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in patients 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age.
Get emergency medical help if you have any signs of an allergic reaction including hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
• feeling like you might pass out
• nosebleed (especially in a child)
• confusion, hallucinations, unusual thoughts
• numbness or tingling around your lips or mouth
• jaundice (yellowing of your skin or eyes)
• dark-colored urine, foul-smelling stools
• fever, stomach pain, loss of appetite
Less serious side effects of Oriel 5 mg tablets may include:
• drowsiness, weakness
• stuffy nose, sinus pain, sore throat, cough
• tired feeling
• dry mouth
• weight gain
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Symptoms of Levocetirizine overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to Generic Xyzal. Should Levocetirizine overdose occur, symptomatic or supportive treatment is recommended.
Levocetirizine Tablets (Generic Xyzal) – Contraindications
Levocetirizine tablets are contraindicated in patients with a known hypersensitivity to Levocetirizine or any of the inactive ingredients of Oriel 5 mg tablets or to Cetirizine. Generic Xyzal is also contraindicated in patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis.
Warnings & Precautions When Using Levocetirizine Tablets (Generic Xyzal)
You should not use Generic Xyzal if you are allergic to levocetirizine or cetirizine (Zyrtec®). Do not take this medicine if you have end-stage kidney disease or if you are on dialysis. Any child under 12 with kidney disease should not take Levocetirizine.
Before taking this medicine, tell your doctor if you are allergic to any drugs, or if you have:
• kidney disease
• liver disease
• gallbladder problems
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medicine.
This medicine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects.
Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Levocetirizine.
Levocetirizine in Pregnancy and Nursing
Levocetirizine has been classified by the US FDA as Pregnancy Category B. There are no adequate and well-controlled studies regarding use of Levocetirizine in pregnant women. Because animal reproduction studies are not always predictive of human response, Generic Xyzal should be used during pregnancy only if clearly needed. Tell your doctor if you are pregnant or plan to become pregnant during treatment with this medicine.
Cetirizine has been reported to be excreted in human breast milk. Because Levocetirizine is also expected to be excreted in human milk, use of Levocetirizine Tablets (Generic Xyzal) in nursing mothers is not recommended. Do not use this medicine without telling your doctor if you are breast-feeding a baby.
Levocetirizine and Alcohol
Patients should be advised to avoid concurrent use of Levocetirizine tablets with alcohol or other central nervous system depressants because additional reduction in mental alertness can occur.