Description
INTRODUCTION
RESTME ORAL SOLUTION contains Hydroxyzine which belongs to the group of medicines called Antihistamines. It is used to treat allergic reactions (itching, sneezing), for anxiety and tension as well as for sedation (for inducing sleep in medical conditions and after anesthesia).
An allergy is an immune response to foreign elements which is not harmful to the body. These foreign elements are known as allergens. Allergic condition varies from person to person. Some might be allergic to some foods and seasonal allergies like hay fever and while others may be allergic to pollen or pet dander. Anxiety is a sense of uneasiness, dread and fear. It might cause feel restless, tense, sweat and have a rapid heartbeat. It may be a usual response to stress.
RESTME ORAL SOLUTION is not recommended for use in patients having porphyria, heart problems and low salt levels in the body. Before taking RESTME ORAL SOLUTION, inform your doctor if you have liver, kidney or mental health problems.
RESTME ORAL SOLUTION is not recommended to use among pregnant and breastfeeding women. Your doctor will prescribe the right dose depends on your child’s age, body weight and health condition.
The most common side effects of taking RESTME ORAL SOLUTION are feeling sleepy, dry mouth, feeling tired, drowsiness and headache. Contact your doctor if any of the above side effects worsen or persist for a longer duration.
USES OF RESTME ORAL SOLUTION
It is used to treat:
Allergic reactions
Itching due to urticaria (nettle rash) and dermatitis
Anxiety (in adults)
HOW RESTME ORAL SOLUTION WORKS
RESTME ORAL SOLUTION works by blocking the action of a chemical messenger (histamine). This relieves allergy indications such as itching, swelling and rashes. In anxiety, it works by decreasing the activity in the brain, thereby helping to feel relaxed/sleepy.
DIRECTIONS FOR USE
Take RESTME ORAL SOLUTION as advised by your physician. Shake well before use. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF RESTME ORAL SOLUTION
COMMON
Feeling sleepy
Dry mouth
Tiredness
Headache
UNCOMMON
Agitation
Confusion
Dizziness
Sleeplessness
Tremors
Nausea
Fever
RARE
Disorientation, hallucinations (seeing things that are not there)
Movement disorder
Low blood pressure
Constipation
Vomiting
Changes in liver enzyme values
Itching, skin rash with redness, spots or blemishes, skin inflammation
Stop taking RESTME ORAL SOLUTION and contact your doctor immediately if you experience any of the following side effects:
Problems with the heart rhythm such as trouble breathing, palpitations or loss of consciousness
Allergic reaction with difficulty in breathing, fever or swelling
Severe allergic reaction (Stevens-Johnson syndrome) (symptoms like fever, inflammation, blistering and ulceration of the skin which can result in the surface layer of the skin peeling away)
Fits (convulsions)
Chest tightening
Blurred vision and have difficulty focusing
An inability to pass urine
HOW TO MANAGE SIDE EFFECTS
Nausea or Vomiting:
Take this medicine with or just after meals. Stick to simple meals. Avoid eating oil-rich or spicy foods.
Headache:
Rest and relax. Drink plenty of fluids such as water. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Consult your doctor if the symptom did not improve.
Dizziness:
If you feel dizzy, keep your eyes closed sit or lie down. Do not drive or operate machinery. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
RESTME ORAL SOLUTION is generally not recommended to use in pregnant women unless considered clearly necessary. Consult your doctor before taking it.
BREASTFEEDING
RESTME ORAL SOLUTION is generally not recommended to use in breastfeeding women as it may pass through breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel drowsy and feel less alert than usual after taking RESTME ORAL SOLUTION.
ALCOHOL
Avoid consumption of alcohol while taking RESTME ORAL SOLUTION as it may increase the risk of side effects.
KIDNEY
RESTME ORAL SOLUTION should be taken with caution in patients with kidney problems and bladder outflow obstruction. Consult your doctor before taking.
LIVER
RESTME ORAL SOLUTION should be taken with caution in patients with liver problems. Consult your doctor before taking.
ALLERGY
Do not take RESTME ORAL SOLUTION if you are allergic to Hydroxyzine or any other piperazine derivatives, aminophylline, ethylenediamine or any of the other ingredients of this medicine.
LUNGS
RESTME ORAL SOLUTION should be taken with caution in patients with breathing problems. Consult your doctor before taking.
HEART DISEASE
RESTME ORAL SOLUTION is not recommended for patients with prolonged QT interval causing irregular heartbeat and/or palpitations or low heart rate. It should be taken with caution in patients with high blood pressure and mild to moderate heart problems. Consult your doctor before taking.
OTHERS
RESTME ORAL SOLUTION is not recommended for use if you:
Have asthma
Have porphyria (a disease that causes constipation, changes in the color of urine, stomach pain, skin rashes and disturbing behavior)
Have low salts levels in the body
Before taking RESTME ORAL SOLUTION, inform your doctor if you:
Have glaucoma (high pressure in the eye)
Have difficulty passing urine (Ex. due to an enlarged prostate)
Have stomach problems
Have myasthenia gravis (a disorder which weakens muscle)
Have dementia
Have epilepsy (fits)
Have hyperthyroidism (overactive thyroid)
Use in pediatrics:
Your doctor will prescribe the right dose and duration depends on your child’s age, body weight and severity of the condition. Consult your doctor before giving RESTME ORAL SOLUTION to your child.
Use in geriatrics:
RESTME ORAL SOLUTION should be used with caution in elderly patients. Consult your doctor before taking the medicine.
INTERACTIONS
A. Drug-Drug interactions:
Before taking RESTME ORAL SOLUTION, inform your doctor if you are taking any of the following medicine:
Medicines used to treat heart problems or high blood pressure (Ex. adrenaline or epinephrine, amiodarone, quinidine, disopyramide, sotalol)
Medicine used to treat sleeping disorders and epilepsy (Ex. barbiturates)
Medicine used to treat ulcers and heartburn (Ex. cimetidine)
Medicine used to treat vomiting and nausea (Ex. antiemetics)
Medicine used to treat Meniere’s disease (Ex. betahistine)
Medicines used as anesthetics
Medicine used as muscle relaxants
Medicine used to treat severe pain (Ex. opioids, methadone)
Medicine used as anticholinergic (including some medicines used for irritable bowel syndrome, asthma or incontinence) (Ex. prucalopride)
Medicine used to treat breathing problems (Ex. aminophylline)
Medicine used to treat bacterial infections (Ex. benzylpenicillin salts and chloramphenicol sodium succinate, erythromycin, moxifloxacin, levofloxacin)
Medicine used for the chemotherapy (Ex. doxorubicin)
Medicine used as antidepressants (Ex. moclobemide or isocarboxazid, citalopram, escitalopram, amitriptyline)
Medicines used to treat anxiety (Ex. alprazolam)
Medicines used to treat psychosis (Ex. haloperidol)
Medicine used as antimuscarinic (Ex. atropine)
Other medicines used as antihistamines (Ex. azelastine, chlorpheniramine)
Medicines used for fungal infections (Ex. pentamidine)
Medicines used to treat malaria (Ex. mefloquine)
Medicines used to treat cancer (Ex. toremifene, vandetanib)
Overdosage:
If you or anyone else accidentally take too much of RESTME ORAL SOLUTION, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage nausea, vomiting, feeling sleepy, confusion, heart palpitations, unreactive pupils, the shakes, hallucinations, breathing problems, fits or low blood pressure.
SYNOPSIS
Drug : Hydroxyzine
Pharmacological Category : Antihistamines
Therapeutic Indication : Treats anxiety and skin conditions (inflammation and itching)
Dosage Forms : Tablet, Syrup, Drops, Injection, Oral drops, Oral solution, Solution
MORE INFORMATION
Keep RESTME ORAL SOLUTION out of reach of children
Store at a temperature, not more than 25°C
FAQs ABOUT RESTME ORAL SOLUTION
What are the common side effects of RESTME ORAL SOLUTION?
The most common side effects of taking RESTME ORAL SOLUTION are feeling sleepy, dry mouth, feeling tired, drowsiness and headache. Contact your doctor if any of the symptoms worsen.
How does RESTME ORAL SOLUTION work for allergies?
RESTME ORAL SOLUTION works by decreasing the inflammation caused by allergies. It reduces inflammation by blocking the release of a natural chemical in our body, called histamine, that causes allergic symptoms such as swelling, redness and pain.
How to take RESTME ORAL SOLUTION?
Take RESTME ORAL SOLUTION as advised by your physician. Shake well before use. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
What if I forget to take a dose of RESTME ORAL SOLUTION?
If you forget a dose of RESTME ORAL SOLUTION, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next scheduled dose at the prescribed time. Do not double the dose to make up for the missed one as this may increase the chances of developing side effects.
Can I stop taking RESTME ORAL SOLUTION when I feel better?
No, do not stop taking RESTME ORAL SOLUTION without consulting your doctor even if you are feeling better. Your symptoms may improve before the condition is completely cured. Therefore, for better and complete treatment, it is advised to continue your treatment for the prescribed duration.
Is RESTME ORAL SOLUTION causes headache?
Headache is the most common side effect of RESTME ORAL SOLUTION. However, it does not affect every individual. Try to rest and relax. If your symptom worsens, consult your doctor.
Can RESTME ORAL SOLUTION be used in pregnant women?
RESTME ORAL SOLUTION is generally not recommended to use among pregnant women unless considered clearly necessary. Consult your doctor before taking RESTME ORAL SOLUTION.
REFERENCES
1. Randal A. Skidgel. Histamine, Bradykinin and Their Antagonists. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018. Page – 711-726.
2. KD. Tripathi. Histamine and Antihistaminics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 159-169.
3. Pierre-Michel Llorca 1, Christian Spadone, Olivier Sol, Anne Danniau, Thierry Bougerol, Emmanuelle Corruble, Michel Faruch, Jean-Paul Macher, Eric Sermet, Dominique Servant. Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study. Journal of Clinical Psychiatry. November 2002. [Accessed on 15th June 2022] https://pubmed.ncbi.nlm.nih.gov/12444816/
4. Amir Garakani1, James W. Murrough, Rafael C. Freire, Robyn P. Thom, Kaitlyn Larkin, Frank D. Buono and Dan V. Iosifescu. Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. Frontiers Psychiatry. December 2020. [Accessed on 15th June 2022] https://www.frontiersin.org/articles/10.3389/fpsyt.2020.595584/full
5. Wenstrup, Susie MD; Hogan, Paul DO; Gonzalez, Ivan MD. Is hydroxyzine effective in reducing anxiety symptoms in adults? Journal of Evidence based Practice. October 2020. [Accessed on 15th June 2022] https://journals.lww.com/ebp/Citation/2020/10000/Is_hydroxyzine_effective_in_reducing_anxiety.25.aspx
6. GSK limited. gskpro.com. [Revised in June 2019] [Accessed on 15th June 2022] https://gskpro.com/content/dam/global/hcpportal/en_SG/products/PDF/atarax/pdf/atarax_pi_ncds06si_approved_17sep19.pdf
PRODUCT DETAILS
Country Of Origin
India
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