Arnica Montana Pellet
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Questions & Answers
Side Effects & Adverse Reactions
Do not use if you have an allergy or hypersensitivity to the components of the formula.
Stop use and ask a doctor if:
- condition worsens
- if symptoms persist for more than 7 days or clear up and occur again within a few days
- rash develops
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Temporarily relieves
- bruising
- swelling
- pain
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Arnica Montana Pellet Manufacturers
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Nartex Laboratorios Homeopaticos Sa De Cv
![Arnica Montana Pellet [Nartex Laboratorios Homeopaticos Sa De Cv]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Arnica Montana Pellet | Nartex Laboratorios Homeopaticos Sa De Cv
Directions
adults and children over 2 years of age: take 3 pellets orally every 6 hours dissolve slowly in mouth children under 2 years of age: consult a physician
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Whole Foods Market
Arnica Montana Pellet | Whole Foods Market
Directions: (adults and children 12 years and older) Dissolve 5 pellets under the tongue 3 times per day until symptoms are relieved or as directed by a doctor.
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Homeolab Usa Inc
Arnica Montana Pellet | Homeolab Usa Inc
(Adults / Children 2-18 years): Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.
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Pharmaca Integrative Pharmacy
Arnica Montana Pellet | Cardinal Health
The long-term use of colchicine is established for FMF and the prophylaxis of gout flares, but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for COLCRYS are different for each indication and must be individualized.
The recommended dosage of COLCRYS depends on the patient's age, renal function, hepatic function and use of coadministered drugs [see Dose Modification for Coadministration of Interacting Drugs (2.4)].
COLCRYS tablets are administered orally without regard to meals.
COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.
2.1 Gout FlaresProphylaxis of Gout Flares
The recommended dosage of COLCRYS for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.
An increase in gout flares may occur after initiation of uric acid-lowering therapy, including pegloticase, febuxostat and allopurinol, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. COLCRYS is recommended upon initiation of gout flare prophylaxis with uric acid-lowering therapy. Prophylactic therapy may be beneficial for at least the first six months of uric acid-lowering therapy.
Treatment of Gout Flares
The recommended dose of COLCRYS for treatment of a gout flare is 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a one hour period. COLCRYS may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later. Wait 12 hours and then resume the prophylactic dose.
2.2 FMFThe recommended dosage of COLCRYS for FMF in adults is 1.2 mg to 2.4 mg daily.
COLCRYS should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily COLCRYS dose may be administered in one to two divided doses.
2.3 Recommended Pediatric DosageProphylaxis and Treatment of Gout Flares
COLCRYS is not recommended for pediatric use in prophylaxis or treatment of gout flares.
FMF
The recommended dosage of COLCRYS for FMF in pediatric patients 4 years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily:
• Children 4 to 6 years: 0.3 mg to 1.8 mg daily • Children 6 to 12 years: 0.9 mg to 1.8 mg daily • Adolescents older than 12 years: 1.2 mg to 2.4 mg daily 2.4 Dose Modification for Coadministration of Interacting DrugsConcomitant Therapy
Coadministration of COLCRYS with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown in the table below [see Drug Interactions (7)].
Table 1 COLCRYS Dose Adjustment for Coadministration with Interacting Drugs if no Alternative Available* * For magnitude of effect on colchicine plasma concentrations [ see Pharmacokinetics (12.3)] † When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [ see Contraindications (4)] ‡ Patients with renal or hepatic impairment should not be given COLCRYS in conjunction with strong CYP3A4 or P-gp inhibitors [ see Contraindications (4)]Strong CYP3A4 Inhibitors2
Drug
Noted or Anticipated Outcome
Gout Flares
FMF
Prophylaxis of Gout Flares
Treatment of Gout Flares
Original Intended Dosage
Adjusted Dose
Original Intended Dosage
Adjusted Dose
Original Intended Dosage
Adjusted Dose
Atazanavir
Clarithromycin
Darunavir/
Ritonavir†
Indinavir
Itraconazole Ketoconazole
Lopinavir/
Ritonavir†
Nefazodone
Nelfinavir
Ritonavir
Saquinavir Telithromycin
Tipranavir/
Ritonavir†Significant increase in colchicine plasma levels*; fatal colchicine toxicity has been reported with clarithromycin, a strong CYP3A4 inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other strong CYP3A4 inhibitors.
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other day1.2 mg
(2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.0.6 mg
(1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.Maximum daily dose of 1.2 – 2.4 mg
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
Moderate CYP3A4 Inhibitors
Drug
Noted or Anticipated Outcome
Gout Flares
FMF
Prophylaxis of Gout Flares
Treatment of Gout Flares
Original Intended Dosage
Adjusted Dose
Original Intended Dosage
Adjusted Dose
Original Intended Dosage
Adjusted Dose
Amprenavir† Aprepitant
Diltiazem Erythromycin Fluconazole Fosamprenavir†
(pro-drug of
Amprenavir)
Grapefruit juice
VerapamilSignificant increase in colchicine plasma concentration is anticipated. Neuromuscular toxicity has been reported with diltiazem and verapamil interactions.
0.6 mg twice a day
0.6 mg once a day0.3 mg twice a day or 0.6 mg once a day
0.3 mg once a day1.2 mg
(2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.1.2 mg
(2 tablets) × 1 dose. Dose to be repeated no earlier than 3 days.Maximum daily dose of 1.2 – 2.4 mg.
Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day)
P-gp Inhibitors‡
Drug
Noted or Anticipated Outcome
Gout Flares
FMF
Prophylaxis of Gout Flares
Treatment of Gout Flares
Original Intended Dosage
Adjusted Dose
Original Intended Dosage
Adjusted Dose
Original Intended Dosage
Adjusted Dose
Cyclosporine Ranolazine
Significant increase in colchicine plasma levels*; fatal colchicine toxicity has been reported with cyclosporine, a P-gp inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other P-gp inhibitors.
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other day1.2 mg
(2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.0.6 mg
(1 tablet) × 1 dose. Dose to be repeated no earlier than 3 days.Maximum daily dose of 1.2 – 2.4 mg
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
Table 2 COLCRYS Dose Adjustment for Coadministration with Protease InhibitorsProtease Inhibitor
Clinical Comment
w/Colchicine - Prophylaxis of Gout Flares
w/Colchicine -
Treatment of Gout Flaresw/Colchicine - Treatment of FMF
Atazanavir sulfate
(Reyataz)Patients with renal or hepatic impairment should not be given colchicine with Reyataz.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayDarunavir (Prezista)
Patients with renal or hepatic impairment should not be given colchicine with Prezista/ritonavir.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayFosamprenavir (Lexiva) with Ritonavir
Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayFosamprenavir (Lexiva)
Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir.
Original dose
Adjusted dose
1.2 mg (2 tablets) × 1 dose. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg twice a day or 0.6 mg once a day
0.3 mg once a dayIndinavir (Crixivan)
Patients with renal or hepatic impairment should not be given colchicine with Crixivan.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayLopinavir/Ritonavir (Kaletra)
Patients with renal or hepatic impairment should not be given colchicine with Kaletra.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayNelfinavir mesylate (Viracept)
Patients with renal or hepatic impairment should not be given colchicine with Viracept.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayRitonavir (Norvir)
Patients with renal or hepatic impairment should not be given colchicine with Norvir.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other daySaquinavir mesylate (Invirase)
Patients with renal or hepatic impairment should not be given colchicine with Invirase/ritonavir.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayTipranavir (Aptivus)
Patients with renal or hepatic impairment should not be given colchicine with Aptivus/ritonavir.
Original dose
Adjusted dose
0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day0.3 mg once a day
0.3 mg once every other dayTreatment of gout flares with COLCRYS is not recommended in patients receiving prophylactic dose of COLCRYS and CYP3A4 inhibitors.
2.5 Dose Modification in Renal ImpairmentColchicine dosing must be individualized according to the patient's renal function [see Renal Impairment (8.6)].
Clcr in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following formula:
[140-age (years) × weight (kg)]
Clcr = --------------------------------------- × 0.85 for female patients
72 × serum creatinine (mg/dL)Gout Flares
Prophylaxis of Gout Flares
For prophylaxis of gout flares in patients with mild (estimated creatinine clearance [Clcr] 50 to 80 mL/min) to moderate (Clcr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg/day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].
Treatment of Gout Flares
For treatment of gout flares in patients with mild (Clcr 50 to 80 mL/min) to moderate (Clcr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. For patients with gout flares requiring repeated courses, consideration should be given to alternate therapy. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). For these patients, the treatment course should not be repeated more than once every two weeks [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].
Treatment of gout flares with COLCRYS is not recommended in patients with renal impairment who are receiving COLCRYS for prophylaxis.
FMF
Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing dialysis. For these patients, the dosage should be reduced [see Clinical Pharmacology (12.3)]. Patients with mild (Clcr 50 to 80 mL/min) and moderate (Clcr 30 to 50 mL/min) renal impairment should be monitored closely for adverse effects of COLCRYS. Dose reduction may be necessary. For patients with severe renal failure (Clcr less than 30 mL/min), start with 0.3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Renal Impairment (8.6)]. For patients undergoing dialysis, the total recommended starting dose should be 0.3 mg (half tablet) per day. Dosing can be increased with close monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].
2.6 Dose Modification in Hepatic ImpairmentGout Flares
Prophylaxis of Gout Flares
For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Hepatic Impairment (8.7)].
Treatment of Gout Flares
For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, a treatment course should be repeated no more than once every two weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Hepatic Impairment (8.7)].
Treatment of gout flares with COLCRYS is not recommended in patients with hepatic impairment who are receiving COLCRYS for prophylaxis.
FMF
Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of colchicine. Dose reduction should be considered in patients with severe hepatic impairment [see Hepatic Impairment (8.7)].
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Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Arnica Montana Pellet | Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
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