Spencet L 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.
Spencet L is used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.
Spencet L is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.
Spencet L may also be used for purposes not listed in this medication guide.
Spencet L indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Seasonal Allergic Rhinitis
Spencet L dihydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
Perennial Allergic Rhinitis
Spencet L dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.
Chronic Idiopathic Urticaria
Spencet L dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
How should I use Spencet L?
Use Spencet L solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Spencet L solution by mouth with or without food. Take it in the evening unless your doctor tells you otherwise.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Spencet L solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Spencet L solution.
Uses of Spencet L in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Spencet L is used to treat symptoms of allergic conditions such as allergic fever (hay fever), year-round allergies like dust or pet allergies and chronic nettle rash.
Spencet L description
Spencet L is a third-generation non-sedative antihistamine indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria. It was developed from the second-generation antihistamine cetirizine. Spencet L is the R-enantiomer of the cetirizine racemate. Spencet L is an inverse agonist that decreases activity at histamine H1 receptors. This in turn prevents the release of other allergy chemicals and increased blood supply to the area, and provides relief from the typical symptoms of hay fever. It does not prevent the actual release of histamine from mast cells. Spencet L was approved by the United States Food and Drug Administration on May 25, 2007 and is marketed under the brand Spencet L® by sanofi-aventis U.S. LLC.
Spencet L dosage
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Spencet L Dosage
Generic name: Spencet L DIHYDROCHLORIDE 5mg
Dosage form: tablet, film coated, oral solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Spencet L is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Spencet L can be taken without regard to food consumption.
Adults and Children 12 Years of Age and Older
The recommended dose of Spencet L is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.
Children 6 to 11 Years of Age
The recommended dose of Spencet L is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults.
Children 6 months to 5 Years of Age
The recommended initial dose of Spencet L is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg.
Dose Adjustment for Renal and Hepatic Impairment
In adults and children 12 years of age and older with:
Mild renal impairment (creatinine clearance [CL CR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended;
Moderate renal impairment (CL CR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended;
Severe renal impairment (CL CR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended;
End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive Spencet L.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.
Drug interaction studies have been performed with racemic cetirizine.
Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline and Pseudoephedrine: Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole and cimetidine. There was a small decrease (approximately 16%) in the clearance of cetirizine caused by theophylline 400 mg dose. It is possible that higher theophylline doses could have a greater effect.
Interactions with Other Medicaments:
No interaction studies have been performed with Spencet L (including no studies with CYP3A4 inducers); studies with the racemate compound, cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple-dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.
The extent of absorption of Spencet L is not reduced with food, although the rate of absorption is decreased.
In sensitive patients the simultaneous administration of cetirizine or Spencet L and alcohol or other CNS depressants, may have effects on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.
Use of Spencet L has been associated with somnolence, fatigue, asthenia, and urinary retention.
Clinical Trials Experience
The safety data described below reflect exposure to Spencet L in 2708 patients with seasonal or perennial allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration.
The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with Spencet L 2.5, 5, or 10 mg once daily in the evening.
The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with seasonal or perennial allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with Spencet L 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with Spencet L 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with Spencet L 1.25 mg once daily for 2 weeks.
The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with Spencet L 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 Spencet L-treated subjects 12-24 months of age.
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 trial of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 years of Age and Older
In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian.
In these trials 43% and 42% of the subjects in the Spencet L 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group.
In placebo-controlled trials of 1-6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity. Somnolence with Spencet L showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%).
Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to Spencet L 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with Spencet L than placebo.
Table 1 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 12 Years and Older Exposed to Spencet L 2.5 mg or 5 mg Once Daily in Placebo-Controlled Clinical Trials 1-6 Weeks in Duration
Adverse Reactions
Spencet L 2.5 mg
(n = 421)
Spencet L 5 mg
(n = 1070)
Placebo
(n = 912)
Somnolence
22 (5%)
61 (6%)
16 (2%)
Nasopharyngitis
25 (6%)
40 (4%)
28 (3%)
Fatigue
5 (1%)
46 (4%)
20 (2%)
Dry Mouth
12 (3%)
26 (2%)
11 (1%)
Pharyngitis
10 (2%)
12 (1%)
9 (1%)
*Rounded to the closest unit percentage
Additional adverse reactions of medical significance observed at a higher incidence than in placebo in adults and adolescents aged 12 years and older exposed to Spencet L are syncope (0.2%) and weight increased (0.5%).
Pediatric Patients 6 To 12 Years Of Age
A total of 243 pediatric patients 6 to 12 years of age received Spencet L 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were 6 to 8 years of age, and 50% were Caucasian. Table 2 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 6 to 12 years exposed to Spencet L 5 mg in placebo-controlled clinical trials and that were more common with Spencet L than placebo.
Table 2 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 6-12 Years Exposed to Spencet L 5 mg Once Daily in Placebo-Controlled Clinical Trials 4 and 6 Weeks in Duration
Adverse Reactions
Spencet L 5 mg
(n = 243)
Placebo
(n = 240)
Pyrexia
10 (4%)
5 (2%)
Cough
8 (3%)
2 ( < 1%)
Somnolence
7 (3%)
1 ( < 1%)
Epistaxis
6 (2%)
1 ( < 1%)
*Rounded to the closest unit percentage
Pediatric Patients 1 To 5 Years Of Age
A total of 114 pediatric patients 1 to 5 years of age received Spencet L 1.25 mg twice daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 3.8 years, 32% were 1 to 2 years of age, 71% were Caucasian and 18% were Black. Table 3 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 1 to 5 years exposed to Spencet L 1.25 mg twice daily in the placebo-controlled safety trial and that were more common with Spencet L than placebo.
Table 3 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 1-5 Years Exposed to Spencet L 1.25 mg Twice Daily in a 2-Week Placebo-Controlled Clinical Trial
Adverse Reactions
Spencet L 1.25 mg Twice Daily
(n = 114)
Placebo
(n = 59)
Pyrexia
5 (4%)
1 (2%)
Diarrhea
4 (4%)
2 (3%)
Vomiting
4 (4%)
2 (3%)
Otitis Media
3 (3%)
0 (0%)
*Rounded to the closest unit percentage
Pediatric Patients 6 To 11 Months Of Age
A total of 45 pediatric patients 6 to 11 months of age received Spencet L 1.25 mg once daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. greater than or equal to 3% of subjects) aged 6 to 11 months exposed to Spencet L 1.25 mg once daily in the placebo-controlled safety trial and that were more common with Spencet L than placebo included diarrhea and constipation which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the Spencet L and placebo-treated groups, respectively.
Long-Term Clinical Trials Experience
In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with Spencet L 5 mg once daily for 4 or 6 months. The patient characteristics and the safety profile were similar to that seen in the short-term studies. Ten (2.3%) patients treated with Spencet L discontinued because of somnolence, fatigue or asthenia compared to 2 ( < 1%) in the placebo group.
There are no long term clinical trials in children below 12 years of age with allergic rhinitis or chronic idiopathic urticaria.
Laboratory Test Abnormalities
Elevations of blood bilirubin and transaminases were reported in < 1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient.
Post-Marketing Experience
In addition to the adverse reactions reported during clinical trials and listed above, adverse reactions have also been identified during post-approval use of Spencet L. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions of hypersensitivity and anaphylaxis, increased appetite, angioedema, fixed drug eruption, pruritus, rash and urticaria, convulsion, paraesthesia, dizziness, tremor, dysgeusia, vertigo, movement disorders (including dystonia and oculogyric crisis), aggression and agitation, hallucinations, depression, insomnia, suicidal ideation, visual disturbances, blurred vision, palpitations, tachycardia, dyspnea, nausea, vomiting, hepatitis, dysuria, urinary retention, myalgia, arthralgia, and edema have been reported.
Besides these reactions reported under treatment with Spencet L, other potentially severe adverse events have been reported from the post-marketing experience with cetirizine. Since Spencet L is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with Spencet L: orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, still birth, tic, myoclonus, and extrapyramidal symptoms.
You should not use this medication if you are allergic to Spencet L or cetirizine (Zyrtec).
Do not take Spencet L if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take Spencet L.
Before taking Spencet L, tell your doctor if you have liver disease, kidney disease, or gallbladder problems.
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 of Spencet L as an adult's body.
Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.
The results of a survey conducted on ndrugs.com for Spencet L 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 Spencet L. 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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