- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The effect of oxymetazoline begins within a few minutes. Occasionally, when administered intranasally, the amount absorbed may be sufficient to cause systemic effects for example at the central nervous system and the cardiovascular system. Further data from pharmacokinetic studies in humans are not available. (Merck, SmPC Nasivin® Nasenspray ohne Konservierungsstoffe Kleinkinder (6109145.00.00))
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Available formulations
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Dosages
| Stuffy nose |
|---|
|
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Children are sensitive to oxymetazoline. Side effects that can occur are heart palpitations, hypertension and nervousness, sleep disorders, very rarely hallucinations and convulsions. Very rarely apnea in newborns and young infants (SmPC Nasiben).
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Intranasal absorption can in rare cases lead to systemic effects.
In infants and children up to 6 years excessive use of oxymetazoline can lead to toxic effects such as loss of consciousness and symptomatic hypotension. Such an overdose can cause severe depression of the central nervous system in toddlers and young children.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
| Sympathomimetics, plain | ||
|---|---|---|
| R01AA08 | ||
| R01AA09 | ||
| R01AA07 | ||
| Sympathomimetics, combinations excl. corticosteroids | ||
|---|---|---|
| R01AB01 | ||
| Antiallergic agents, excl. corticosteroids | ||
|---|---|---|
| R01AC03 | ||
| R01AC01 | ||
| R01AC02 | ||
| Corticosteroids | ||
|---|---|---|
| R01AD58 | ||
| R01AD01 | ||
| R01AD05 | ||
| R01AD08 | ||
| R01AD12 | ||
| R01AD12 | ||
| R01AD09 | ||
| R01AD59 | ||
| R01AD11 | ||
| Other nasal preparations | ||
|---|---|---|
| R01AX10 | ||
| OTHER NASAL PREPARATIONS | ||
|---|---|---|
| R01AX10 | ||
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
References
- CHMP, EPAR Oxymetazolin, www.ema.europa.eu
- Merck Selbstmedikation GmbH, SmPC Nasivin 0,025% (RVG 26124) 16-05-2011, www.geneesmiddeleninformatiebank.nl
- Merck Selbstmedikation GmbH, SmPC Nasivin 0,01% (RVG 29857) 16-05-2011, www.geneesmiddeleninformatiebank.nl
- Merck Selbstmedikation GmbH, SmPC Nasivin 0,05% (RVG 00848/00849/19073) 16-05-2011, www.geneesmiddeleninformatiebank.nl
- WICK Pharma, SmPC WICK Sinex Schnupfenspray 0,5 mg/ml (Reg.-Nr. 48887), 02/2015
- WICK Pharma, SmPC WICK Sinex avera Nasenspray 0,5 mg/ml (50661.00.00), 09/2017
- Merck Selbstmedikation, SmPC Nasivin® Nasenspray ohne Konservierungsstoffe Erwachsene und Schulkinder (3494.00.01), 02/2017
- Merck Selbstmedikation, SmPC Nasivin® Nasentropfen/Spray/Dosierspray für Erwachsene und Schulkinder (6108938.00.01/ 6108938.00.00/ 6462346.00.00), 05/2014
- Merck Selbstmedikation, SmPC Nasivin® Nasenspray ohne Konservierungsstoffe Kleinkinder (6109145.00.00), 03/2017
- Merck Selbstmedikation, SmPC Nasivin® Dosiertropfer ohne Konservierungsstoffe Baby (6109145.01.00), 03/2017
- P&G Health Germany, SmPC Nasiben Baby sanft 0,01%-Dosiertropfer (1-27063), https://aspregister.basg.gv.at/, aufgerufen am 22.01.2021
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Changes
Changes
