Levorid-D (Levocetirizine and Phenylephrine Tablets)

Levorid-D (Levocetirizine and Phenylephrine Tablets) is used for the relief of the symptoms of allergic rhinitis such as sneezing, rhinorrhoea, nasal congestion, itching and lacrimation.

1. Levocetirizine and Phenylephrine Tablets
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Levorid-D (Levocetirizine and Phenylephrine
Tablets) is used for the relief of the symptoms of
allergic rhinitis such as sneezing, rhinorrhoea,
nasal congestion, itching and lacrimation.

2. Levorid-D Tablets
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Levorid-D Tablets are manufactured
by Cipla Limited, India.
(Website: www.cipla.com)

3. Levocetirizine DihydrochlorideTablets – Brand
Names
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Levocetirizine Dihydrochloride and
Phenylephrine tablets are
available as Levorid-D, Levostar-
D and Sinarest Levo.

4. Active Ingredient
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The active ingredients contained in Levorid-D
tablets are Levocetirizine Dihydrochloride
and Phenylephrine Hydrochloride. Each film
coated Levorid-D tablet contains 2.5 mg of
Levocetirizine and 10 mg of Phenylephrine.

5. Chemical Structure
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The structure of Phenylephrine Hydrochloride
is given below:

6. Chemical Structure
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The structure of Levocetirizine Dihydrochloride
is given below:

7. Uses of Levorid-D Tablets
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Levorid-D tablets manufactured by Cipla
Limited, India are used for prompt,
temporary relief of sneezing, itchy, watery
eyes, itchy nose or throat, and runny
nose caused by Seasonal allergic rhinitis
and Perennial allergic rhinitis.

8. Levocetirizine and Phenylephrine Tablets Dosage

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➢Adults and Adolescents (12 years and
above): One tablet twice daily.
➢The recommended dosage should not be
exceeded.
The dosage of Levorid-D tablets (Levocetirizine
and Phenylephrine) is given below:

9. Storage Instructions

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Levorid-D (Levocetirizine and
Phenylephrine Tablets) have to be
stored at controlled room temperature
i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

10. Levorid-D Tablets
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Contraindications
Levorid-D is contraindicated in patients with a
hypersensitivity to Levocetirizine Dihydrochloride,
Cetirizine or its parent compound hydroxyzine,
Phenyleprine, or any other ingredient of this medication.
Patients with end-stage renal impairment of less than 10
mL/min creatinine clearance or patients undergoing
hemodialysis.
Children 6 to 11 years of age with renal impairment
Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
Levorid-D is contraindicated in patients receiving
concurrent administration of monoamine oxidase
inhibitors or within 14 days of stopping such treatment.

11. Levorid-D Tablets
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Contraindications
Levorid-D must be avoided in patients on tricyclic
antidepressants.
Levorid-D tablets are also contraindicated in patients
with cardiovascular diseases, hypertension, aortic
aneurysm, severe or unstable ischaemic heart
disease, such as angina and recent myocardial
infarction, hyperthyroidism, diabetes mellitus, closed
angle glaucoma, prostatic enlargement and
phaeochromocytoma.
Since Phenylephrine has actions that promote
smooth muscle contractility, including in the uterus,
and may induce umbilical vasospasm, it should be
avoided in pregnancy.

12. Warnings

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During clinical trials the occurrence of somnolence, fatigue, and
asthenia has been reported in some patients under therapy with
Levocetirizine. Avoid engaging in hazardous occupations requiring
complete mental alertness such as driving or operating machinery
when undergoing therapy with Levorid-D tablets.
Avoid concurrent use of alcohol or other central nervous system
depressants with Levocetirizine Dihydrochloride, a constituent of
Levorid-D .
The use of this formulation is not recommended in children aged
less than 6 years since this formulation does not allow for
appropriate dose adaptation.
Urinary retention has been reported post-marketing with
Levocetirizine.
Levorid-D must be used with caution in patients having
predisposing factors of urinary retention (e.g. spinal cord lesion,
prostatic hyperplasia) as Levocetirizine can increase the risk of
urinary retention.

13. Warnings

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Care must be exercised in the use of Phenylephrine, a
constituent of Levorid-D tablets in patients with
ischaemic heart disease since agonists at alpha1-
adrenoceptors may produce coronary vasospasm.
In patients with chronic pulmonary hypertension and right
ventricular failure, using phenylephrine to increase right
ventricular coronary perfusion pressure by increasing the
aortic blood pressure leads to detrimental effects on the
right ventricular function and is not recommended.
Phenylephrine should be used with caution in patients
with occlusive vascular disease including Raynaud’s
Phenomenon.
In cirrhosis, there is a reduction in vascular alpha-
adrenergic responsiveness and larger doses of
Phenylephrine may be required for any desired effect.

14. Warnings

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Concurrent administration of monoamine oxidase
inhibitors is an absolute contraindication.
Severe or unpredictable increases in blood pressure
may occur if the patient is receiving concurrent
treatment with a monoamine oxidase inhibitor drug
as a result of increased receptor sensitivity.
Since Phenylephrine has actions that promote
smooth muscle contractility, including in the uterus,
and may induce umbilical vasospasm, it must be
avoided in pregnancy.
Phenylpehrine must not be administered
concomitantly with tricyclic antidepressants and in
patients with hypertension, unstable angina and
recent myocardial infarction, and hyperthyroidism.

15. Levocetirizine & Phenylephrine Tablets Side Effects
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➢Common Levorid-D (Levocetirizine and Phenylephrine Tablets)
side effects due to Levocetirizine can include somnolence,
headache, fatigue, nasopharyngitis, dry mouth, and pharyngitis in
subjects 12 years of age and older and pyrexia, somnolence,
cough, and epistaxis in children 6 to 12 years of age.
➢ Further uncommon incidences of adverse reactions like
asthenia or abdominal pain and urinary retention were observed.
Additional side effects of medical significance observed at a
higher incidence than in placebo in adults and adolescents aged
12 years and older exposed to Levocetirizine are syncope (0.2%)
and weight increased (0.5%).
➢Side effects observed in patients 1 to 5 years of age and in 6
months to 11 months of age were pyrexia, diarrhoea, vomiting,
otitis media, constipation, salivary hypersecretion, thirst, hunger,
fatigue, anorexia, somnolence, psychomotor hyperactivity, sleep
disorder, middle insomnia, epistaxis, pruritius, headache.

16. Levocetirizine Side Effects
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➢In addition to the adverse reactions reported during clinical
studies and listed above, very rare cases of the following
Levocetirizine side effects have been reported during post-
marketing experience
➢Immune System Disorders: Hypersensitivity including
anaphylaxis
➢Metabolism and Nutrition Disorders: Increased appetite
➢Psychiatric Disorders: Aggression, agitation, hallucinations,
depression, insomnia, suicidal ideation.
➢Nervous System Disorders: Convulsion, paraesthesia,
dizziness, syncope, tremor, dysguesia.
➢Ear and Labyrinth Disorder: Vertigo
➢Eyes Disorders: Visual disturbances, blurred vision
➢Cardiac Disorders: Palpitations, tachycardia
➢Respiratory, Thoracic, and Mediastinal Disorders: Dyspnoea

17. Levocetirizine Side Effects
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➢Gastrointestinal Disorders: Nausea, vomiting,
diarrhoea
➢Hepatobiliary Disorders: Hepatitis
➢Skin and Subcutaneous Tissue Disorders:
Angioneurotic oedema, fixed drug eruption, pruritus,
rash, urticaria
➢Musculoskeletal, Connective Tissues, and Bone
Disorders: Myalgia, Arthralgia
➢Investigations: Weight increased, abnormal liver
function tests
➢Renal and Urinary Disorders: dysuria, urinary
retention
➢General Disorders and Administration Site
Conditions: oedema

18. Phenylephrine Side Effects
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➢Persistent and/or severe hypertension is a potentially
lethal hazard of the response to Phenylephrine. Severe
hypertension complicated by headache, nausea,
vomiting and profound reflex bradycardia has been
reported, and infants and young children appear to be
especially at risk. Rarely, palpitations, allergic
reactions and occasionally urinary retention in males.
➢The vasoconstrictor and pressor effects of
phenylephrine could be hazardous to patients who are
also suffering from hypertension, aortic aneurysm,
severe or unstable ischaemic heart disease or
hyperthyroidism.

19. Phenylephrine Side Effects
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➢Severe or unpredictable increases in blood pressure
may occur if the patient is receiving concurrent
treatment with a monoamine oxidase inhibitor drug, as
a result of increased receptor sensitivity.
➢Severe tissue necrosis may occur if potent
vasopressors such as Phenylephrine are injected other
than intravenously. Local application to the conjunctiva
may cause stinging.
➢Administration of phenylephrine, like other alpha1-
adrenergic agents, interferes with potassium movement
into the cells during acute potassium administration,
although normally there is no effect on serum
potassium.

20. Levocetirizine Dihydrochloride Overdose
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Symptoms of Levocetirizine
Dihydrochloride overdose could
include drowsiness in adults, and in
children, initially agitation and
restlessness, followed by
drowsiness.

21. Phenylephrine Hydrochloride Overdose
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Symptoms of severe overdosage of Phenylephrine
include haemodynamic changes and
cardiovascular collapse with respiratory
depression.
Phenylephrine overdose is likely to result in:
irritability, restlessness, nervousness, headache,
difficulty in micturition, dizziness,thirst, convulsions,
insomnia, increased blood pressure, nausea,
vomiting, Mydriasis, acute angle closure glaucoma
(most likely to occur in those with closed angle
glaucoma), tachycardia, palpitations, allergic
reactions (e.g. rash, urticaria, allergic dermatitis),
dysuria, urinary retention.

22. Levorid-D Tablets Overdose
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There is no known specific antidote to Levorid-D
(Levocetirizine and Phenylephrine Tablets). In case
Levorid-D overdose occurs consider standard
measures to remove any unabsorbed medicine.
Gastric lavage should be considered following short-
term ingestion. Levocetirizine is not effectively
removed by haemodialysis.
Phenylephrine overdose treatment includes early
gastric lavage and symptomatic and supportive
measures. Hypertensive effects may be treated with
an i.v. alpha-receptor-blocking agent.
In most cases, a severe hypertensive response can
be countered by means of an alpha1-antagonist, such
as intravenous Phentolamine.

23. Levorid-D During Pregnancy
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Levocetirizine Dihydrochloride has been classified
by the US FDA as Pregnancy Category B. There
are no adequate and well-controlled studies of
Levocetirizine conducted in pregnant women.
Phenylephrine has been classified as pregnancy
category C by the FDA. Animal studies have not
been reported. There are no controlled data in
human pregnancy.
Due to the fact that animal reproduction studies
are not always predictive of human response,
Levorid-D (Levocetirizine and Phenylephrine
Tablets) should be used during pregnancy only if
clearly required.

24. Levorid-D Tablets
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Levorid-D Tablets click here
© Clearsky Pharmacy
Levorid-D (Levocetirizine and Phenylephrine
Tablets) by Cipla Limited, India.