Denovals

Denovals Uses, Dosage, Side Effects, Food Interaction and all others data.

Denovals is a long-acting, tricyclic, non-sedating, selective peripheral histamine H1-receptor antagonist which inhibits the release of pro-inflammatory mediators from human mast cells and basophils.

Denovals is a long-acting second-generation H1-receptor antagonist which has a selective and peripheral H1-antagonist action. Histamine is a chemical that causes many of the signs that are part of allergic reactions, such as the swelling of tissues. Histamine is released from histamine-storing cells (mast cells) and attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be "activated," releasing other chemicals which produce the effects that we associate with allergies. Denovals blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of cells by histamine. Unlike most other antihistamines, Denovals does not enter the brain from the blood and, therefore, does not cause drowsiness.

Trade Name Denovals
Availability Prescription only
Generic Desloratadine
Desloratadine Other Names Descarboethoxyloratadine, Desloratadina, Desloratadine
Related Drugs prednisone, cetirizine, loratadine, fluticasone nasal, promethazine, diphenhydramine, Zyrtec, Xolair
Type
Formula C19H19ClN2
Weight Average: 310.821
Monoisotopic: 310.123676325
Protein binding

Desloratadine is bound approximately 82 to 87% to plasma proteins, while its active metabolite, 3-hydroxydesloratadine, is bound approximately 85 to 89%.

Groups Approved, Investigational
Therapeutic Class Non-sedating antihistamines
Manufacturer
Available Country Poland
Last Updated: September 19, 2023 at 7:00 am
Denovals
Denovals

Uses

Allergic Rhinitis: Denovals is used for the relief of the nasal and non-nasal symptoms of allergic rhinitis (Both seasonal and perennial) in patients 2 years of age and older.

Chronic Idiopathic Urticaria: Denovals is also used for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 2 years of age and older.

Denovals is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Asthma, Chronic Idiopathic Urticaria, Common Cold, Nasal Congestion, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis, Nasal symptoms, Non-nasal symptoms, Antihistamine

How Denovals works

Like other H1-blockers, Denovals competes with free histamine for binding at H1-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine.

Dosage

Denovals dosage

Pediatric drops :

  • Child 6 -11 months of age: 2 ml drops once daily
  • Child 1 -2 years of age: 2.5 ml drops once daily

Syrup:

  • Child 6-11 months of age: 2 ml once daily
  • Child 1-5 years of age: 2.5 ml once daily
  • Child 6-11 years of age: 5 ml once daily
  • Adults & > 12 years of age: 10 ml once daily

Tablet:

  • Adults and children 12 years of age and over: 5 mg daily

Side Effects

Denovals is generally well tolerated. However, dry mouth, fatigue, somnolence and myalgia are commonly reported side-effects. Less common side-effects may include dizziness, headache and nausea. Rarely rash, pruritus and urticaria may occur.

Toxicity

Information regarding desloratadine overdose is limited, although somnolence has been reported. In case of overdose, symptomatic and supportive treatment, including removing the unabsorbed drug, is recommended; note, however, that desloratadine and its active metabolite 3-hydroxydesloratadine cannot be eliminated by hemodialysis.

In animal studies, lethality was observed at or above doses of 250 mg/kg in rats and of 353 mg/kg in mice (oral LD50), doses that represent 120 and 290 times the human exposure based on the recommended daily oral dose. In monkey, no deaths occurred at doses up to 250 mg/kg, representing an exposure roughly 810 times that of the recommended dose in humans.

Precaution

Hepatic and renal impairment. Pregnancy and lactation.

Interaction

Concomitant administration of Erythromycin, Ketoconazole, Azithromycin, Fluoxetine, and Cimetidine with Denovals increased the plasma concentration of Denovals. But there were no clinically relevant changes in the safety profile of Denovals.

Food Interaction

  • Take with or without food. The absorption is unaffected by food.

Denovals Disease Interaction

Moderate: asthma, renal/hepatic impairment

Elimination Route

Denovals administered orally for ten days to healthy volunteers as a 5 mg tablet once daily resulted in a mean Tmax of approximately 3 hours, a mean steady-state Cmax of 4 ng/ml, and a mean steady-state AUC of 56.9 ng*hr/ml. A similar profile was observed using 10 ml of an oral solution containing 5 mg of desloratadine. Food was found not to affect desloratadine absorption.

Half Life

Denovals has a mean plasma elimination half-life of approximately 27 hours.

Elimination Route

Approximately 87% of a C-desloratadine dose was equally recovered in urine and feces as metabolic products.

Pregnancy & Breastfeeding use

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Denovals should be used in pregnancy only if clearly needed.

Lactation: Denovals passes into breast milk. Therefore, a decision should be made whether to discontinue nursing or to discontinue Denovals, taking into account the importance of the drug to the mother.

Contraindication

Denovals is contraindicated in patient having hypersensitivity to this medication or to any of its ingredients or Loratadine.

Special Warning

Paediatric Use: The safety and effectiveness of Denovals in pediatric patients under 2 years of age have not been established.

Geriatric Use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data.

Acute Overdose

No clinically relevant adverse events have been reported in case of overdosage. However, in the event of overdosage, symptomatic and supportive treatment is recommended.

Storage Condition

Store in a cool and dry place, protected from light.

Innovators Monograph

You find simplified version here Denovals

Denovals contains Desloratadine see full prescribing information from innovator Denovals Monograph, Denovals MSDS, Denovals FDA label

FAQ

What is Denovals used for?

Denovals is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. Denovals is used to treat allergies. It is an active metabolite of loratadine. It is used to relieve the symptoms of hay fever and hives of the skin.

How safe is Denovals?

Denovals is a safe and effective treatment for allergic diseases.

How does Denovals work?

Denovals works by blocking histamine, a substance in the body that causes allergic symptoms.

What are the common side effects of Denovals?

Common side effects of Denovals are include:

  • headache.
  • nausea.
  • diarrhea.
  • dizziness.
  • sore throat.
  • dry mouth.
  • muscle pain.
  • extreme tiredness

Is Denovals safe during pregnancy?

As such these findings provide reassurance by indicating that the fetal safety of Denovals is similar to the currently recommended antihistamines during pregnancy and thus Denovals can be considered to be another option for use during pregnancy.

Is Denovals safe during breastfeeding?

Considering the minimal exposure of a nursing infant to the drugs through breast milk, maternal use of Denovals dose is unlikely to result in adverse effects in nursing infants and is considered to be compatible with breastfeeding.

Can I drink alcohol with Denovals?

Denovals alone or in combination with alcohol was safe and well tolerated.

Can I drive after taking Denovals?

Do not drive and do not use tools or machines.

When should be taken of Denovals?

You can take Denovals before or after meals.

Can I take Denovals every day?

The recommended dose of Denovals tablets is one 5 mg tablet once daily.

How long does Denovals take to work?

Denovals is also use to relieve the symptoms of allergic skin conditions  such as skin itch and hives. Denovals usually starts to work within 75 minutes and lasts for 24 hours.

What is the half-life of Denovals ?

The 27-hour half-life of Denovals permits once daily administration.

How long can I take Denovals for?

You can limit treatment to 14 days.

Can I take Denovals for a long time?

Denovals is unlikely to do you any harm if you take it for a long time. However, it's best to take it only for as long as you need to. It's best not to drink alcohol while you're taking Denovals, as it can make you feel sleepy.

Who should not take Denovals?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happen if I overdose of Denovals?

tiredness. sleepiness. menstrual pain. Increased sleepiness or tiredness can happen if you take more Denovals than your doctor prescribed to you.

Can Denovals cause infertility?

Denovals is not expected to cause other pregnancy problems.

Does Denovals increase blood pressure?

The decongestant in Denovals  and pseudoephedrine may cause blood pressure to increase and may also speed up the heart rate.

Can Denovals affects my kidney?

Older patients are more likely to have kidney or liver problems which may make them more sensitive to the effects of Denovals. Your doctor may give you a different Denovals dose if you have kidney or liver problems.

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*** Taking medicines without doctor's advice can cause long-term problems.
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