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Paremyd
Overview
What is Paremyd?
PAREMYD sterile ophthalmic solution is a topical mydriatic combination product for ophthalmic use.
STRUCTURAL FORMULAE
CHEMICAL NAME
CONTAINS
Actives:
Preservative:
Inactives:
What does Paremyd look like?
What are the available doses of Paremyd?
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What should I talk to my health care provider before I take Paremyd?
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How should I use Paremyd?
PAREMYD Solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. PAREMYD provides clinically significant mydriasis with partial cycloplegia.
One to two drops in the conjunctival sac. The onset of action with PAREMYD Solution occurs within 15 minutes followed by maximum effect within 60 minutes. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours.
Mydriasis will reverse spontaneously with time, typically in 6 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
What interacts with Paremyd?
PAREMYD Solution should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.
What are the warnings of Paremyd?
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
For topical ophthalmic use only; not for injection.
There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma.
This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children or the aged. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic drugs.
What are the precautions of Paremyd?
General
Patients with hypertension, hyperthyroidism, diabetes or cardiac disease (i.e., arrhythmias or chronic ischemic heart disease) should be monitored after instillation. The elderly and others in whom glaucoma or increased intraocular pressure may be encountered following administration of PAREMYD Solution should also be monitored closely. To avoid inducing angle-closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.
Information for Patients
Patients should be advised not to touch the dropper tip to any surface since this may contaminate the solution. Patients should be advised to use caution when driving or engaging in other hazardous activities while pupils are dilated. Patients may experience photophobia and/or blurred vision and should protect their eyes in bright illumination when pupils are dilated. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.
Carcinogenesis, mutagenesis, impairment of fertility
No studies have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of PAREMYD.
Pregnancy
Animal reproduction studies have not been conducted with PAREMYD. It is also not known whether PAREMYD can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. PAREMYD should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAREMYD is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. PAREMYD may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs. (See ). Keep this and all medications out of the reach of children.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
What are the side effects of Paremyd?
Increased intraocular pressure has been reported following use of mydriatics. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, allergic reactions, nausea, vomiting, pallor and muscle rigidity have been reported with the use of tropicamide and/or hydroxyamphetamine hydrobromide, and thus may occur with PAREMYD Solution. Central nervous system disturbances have also been reported. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs.
Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following PAREMYD instillation.
What should I look out for while using Paremyd?
PAREMYD Solution should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.
For topical ophthalmic use only; not for injection.
There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma.
This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children or the aged. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic drugs.
What might happen if I take too much Paremyd?
Ocular overdosage will cause dilation of the pupils. Systemic overdosage or ingestion of large doses may result in hypertension, cardiac arrhythmias, sub-sternal discomfort, headache, sweating, nausea, vomiting and gastrointestinal irritation. Patients with systemic overdosage should be carefully monitored and treated symptomatically.
How should I store and handle Paremyd?
PAREMYD (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% as a 15 mL solution in a 15 mL opaque white, low density polyethylene bottle with a natural low density polyethylene dropper tip and a red polypropylene cap.15 mL - NDC 17478-704-12PAREMYD (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% as a 15 mL solution in a 15 mL opaque white, low density polyethylene bottle with a natural low density polyethylene dropper tip and a red polypropylene cap.15 mL - NDC 17478-704-12
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
PAREMYD Solution combines the effects of the adrenergic agent, hydroxyamphetamine hydrobromide, and the anticholinergic agent, tropicamide.
Hydroxyamphetamine hydrobromide is an indirectly-acting sympathomimetic agent which, when applied topically to the eye, causes the release of endogenous norepinephrine from intact adrenergic nerve terminals resulting in mydriasis. Since hydroxyamphetamine hydrobromide has little or no direct activity on the receptor site, dilation does not usually occur if there is damage to the presynaptic nerve terminal, e.g., Horner's Syndrome. However, it is not known whether damage to the presynaptic nerve terminal will influence the extent of mydriasis produced by PAREMYD. Hydroxyamphetamine hydrobromide has minimal cycloplegic action.
Tropicamide is a parasympatholytic agent which, when applied topically to the eye, blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle. Tropicamide produces short-duration mydriasis. Although cycloplegia occurs with higher doses of tropicamide, there is evidence with 0.25% tropicamide that full cycloplegia does not occur.
Since both these agents act on different effector sites, their simultaneous use produces an additive mydriatic effect. PAREMYD provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. The onset of action with PAREMYD occurs within 15 minutes, followed by maximum effect within 60 minutes after instillation of one drop. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours, with recovery beginning at approximately 90 minutes and with complete recovery occurring in most patients in 6 to 8 hours. However, in some cases complete recovery may take up to 24 hours. Effectiveness may differ slightly in patients with light and dark irides, with those patients with light irides experiencing a slightly greater mydriasis.
Non-Clinical Toxicology
PAREMYD Solution should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.For topical ophthalmic use only; not for injection.
There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma.
This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children or the aged. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic drugs.
CYP2D6 Inhibitors
Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Acetaminophen and Codeine Phosphate Oral Solution and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of Acetaminophen and Codeine Phosphate Oral Solution is achieved [see ].
After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease but the active metabolite morphine plasma concentration will increase, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression [see ].
If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Acetaminophen and Codeine Phosphate Oral Solution and monitor patients closely at frequent intervals.
If concomitant use with CYP2D6 inhibitors is necessary, follow the patient for reduced efficacy or signs and symptoms of opioid withdrawal and consider increasing the Acetaminophen and Codeine Phosphate Oral Solution as needed.
After stopping use of a CYP2D6 inhibitor, consider reducing the Acetaminophen and Codeine Phosphate Oral Solution and monitor the patient for signs and symptoms of respiratory depression or sedation.
CYP3A4 Inhibitors
The concomitant use of Acetaminophen and Codeine Phosphate Oral Solution and CYP3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations, with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Acetaminophen and Codeine Phosphate Oral Solution is achieved [see ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine.
If concomitant use of CYP3A4 inhibitor is necessary, consider dosage reduction of Acetaminophen and Codeine Phosphate Oral Solution until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the Acetaminophen and Codeine Phosphate Oral Solution dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
CYP3A4 Inducers
The concomitant use of Acetaminophen and Codeine Phosphate Oral Solution and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence [see ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, codeine plasma concentrations may increase, with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy and signs of opioid withdrawal and consider increasing the Acetaminophen and Codeine Phosphate Oral Solution dosage as needed.
If a CYP3A4 inducer is discontinued, consider a Acetaminophen and Codeine Phosphate Oral Solution dosage reduction and monitor for signs of respiratory depression and sedation at frequent intervals.
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see].
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see ].If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Acetaminophen and Codeine Phosphate Oral Solution if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity.
Advise patients taking Acetaminophen and Codeine Phosphate Oral Solution not to use MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of Acetaminophen and Codeine Phosphate Oral Solution and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
Acetaminophen and Codeine Phosphate Oral Solution may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Acetaminophen and Codeine Phosphate Oral Solution and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Acetaminophen and Codeine Phosphate Oral Solution is used concomitantly with anticholinergic drugs.
Patients with hypertension, hyperthyroidism, diabetes or cardiac disease (i.e., arrhythmias or chronic ischemic heart disease) should be monitored after instillation. The elderly and others in whom glaucoma or increased intraocular pressure may be encountered following administration of PAREMYD Solution should also be monitored closely. To avoid inducing angle-closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.
Increased intraocular pressure has been reported following use of mydriatics. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, allergic reactions, nausea, vomiting, pallor and muscle rigidity have been reported with the use of tropicamide and/or hydroxyamphetamine hydrobromide, and thus may occur with PAREMYD Solution. Central nervous system disturbances have also been reported. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs.
Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following PAREMYD instillation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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